Mobile high frequency chest wall oscillation system

ABSTRACT

A therapy system is operable to deliver at least one respiratory therapy to a patient. For example, therapy system may be operable to deliver any one or more of the following therapies: a high frequency chest wall oscillation (HFCWO) therapy, a positive expiratory pressure (PEP) therapy, a nebulizer therapy, an intermittent positive pressure breathing (IPPB) therapy, a cough assist therapy, a suction therapy, a bronchial dilator therapy, and the like. The therapy system is contained in a housing supported by a mobile stand.

This application is a continuation of U.S. patent application Ser. No.11/685,285, which was filed Mar. 13, 2007, which claimed the benefit,under 35 U.S.C. § 119(e), of U.S. Provisional Application No. 60/782,383which was filed Mar. 15, 2006, and each of which is hereby incorporatedby reference herein.

BACKGROUND OF THE INVENTION

The present disclosure relates generally to high frequency chest walloscillation (HFCWO) therapy systems, and more particularly, to HFCWOtherapy systems suitable for use in a hospital or healthcare facility.

Manual percussion techniques of chest physiotherapy have been used for avariety of diseases, such as cystic fibrosis, emphysema, asthma andchronic bronchitis, to remove excess mucus that collects in the lungs.To bypass dependency on a caregiver to provide this therapy, chest walloscillation devices have been developed to deliver HFCWO therapy to apatient. U.S. Patent Application Publication No. US 2004/0097842discloses an illustrative HFCWO therapy system, which is herebyincorporated by reference herein.

SUMMARY OF THE INVENTION

The present invention comprises an apparatus or system that has one ormore of the following features or combinations thereof, which alone orin any combination may comprise patentable subject matter:

The apparatus may comprise a housing and a therapy system carried by thehousing and operable to deliver one or more respiratory therapies to apatient. The apparatus may further comprise an assessment system carriedby the housing and operable to assess the efficacy of at least one ofthe respiratory therapies. The therapy system may be operable to deliverany one or more of the following therapies: HFCWO therapy, a positiveexpiratory pressure (PEP) therapy, a nebulizer therapy, an intermittentpositive pressure breathing (IPPB) therapy, a cough assist therapyand/or other types of suction therapy (e.g., negative pressure woundtherapy), and a bronchial dilator therapy. The assessment system maycomprise any one or more of the following devices: a flow meter, aspirometer, an electronic stethoscope, a tympanic thermometer, a pulseoximeter, and a respiration rate monitor.

The apparatus may include a display operable to show data relating tothe therapy system and/or relating to the assessment system. Theapparatus may include a controller operable to control at least two ofthe respiratory therapies. In some embodiments, the controller isoperable to control the assessment system and at least one of therespiratory therapies. Data from the assessment system may be used toadjust at least one of the respiratory therapies. In some embodiments,data from the assessment system is used to adjust the frequency andintensity of the HFCWO therapy.

The therapy system may comprise an air pulse generator operable toprovide a pressure having a steady state pressure component and anoscillating pressure component. The therapy system may include acontroller operable to control the amplitude of the steady statepressure component, the frequency of the oscillating pressure componentand the duration of the HFCWO therapy. The display may be operable toshow data relating to the HFCWO therapy. The controller may analyze datafrom a spirometer and show the data on the display. Data from thespirometer may be used to adjust the amplitude of the steady statepressure component and the frequency of the oscillating pressurecomponent. The apparatus may include a nebulizer coupled to apressurized air source located within the housing. The pressurized airsource may comprise a compressor.

The apparatus may comprise a self-oscillating valve coupled to a sourceof pressurized air and an air amplifier that is coupled to theself-oscillating valve and that is coupled to an inflatable bladder. Thepressurized air source may comprise a hospital pressurized air outlet.The self-oscillating valve may be driven by pressurized air from thepressurized air source to produce first pressure pulses having a firstpressure and a first volume flow rate for application to the airamplifier. The air amplifier may convert the first pressure pulses intosecond pressure pulses that are communicated to the bladder. The secondpressure pulses may have a second pressure that is smaller than thefirst pressure and having a second volume flow rate that is greater thanthe first volume flow rate. The apparatus may have a pressure controloperable to vary the amplitude of the air pulses, a frequency controloperable to vary the frequency of the air pulses, and a timer control toprovide an alarm signal to indicate that the set therapy time haselapsed. The air pulse generator may include a housing having a hangerconfigured to suspend the housing from a support device, such as achair, a hospital bed, a cart, a wheeled pedestal, or a rollable stand.The self-oscillating valve and the air amplifier may be located withinthe housing.

The apparatus may comprise a housing, an air pulse generator carried bythe housing and operable to deliver HFCWO therapy to a patient, acontroller carried by the housing and operable to control the HFCWOtherapy, and a wheeled pedestal coupled to the housing. A storagecompartment may be coupled to the pedestal. The pedestal may bevertically adjustable to support the housing at a selected one of aplurality of elevations. The apparatus may include a remote on/offswitch coupled to the controller. Supplies associated with the HFCWOtherapy may be stored in the storage compartment. The storagecompartment may be located below the housing. The storage compartmentmay comprise a pair of bins mounted on opposite sides of the pedestal.The bins may have hinged lids. The housing may include a handle that isgripped to maneuver the housing and the wheeled pedestal along a floor.

The apparatus may comprise a wheeled housing having a first storagecompartment, a respiratory therapy system carried by the housing andoperable to deliver respiratory therapy to a patient, and a displaycarried by the housing and operable to show data relating to therespiratory therapy. The display may be movable between a first positionin which the first storage compartment is accessible and a secondposition in which the display blocks access to the first storagecompartment. The housing may further comprise a second storagecompartment located below the first storage compartment. The apparatusmay include an assessment system carried by the housing and operable toassess the efficacy of the respiratory therapy. The assessment systemmay comprise a spirometer. The apparatus may include a controllercarried by the housing and operable to control the respiratory therapy.The respiratory therapy system may system comprise a HFCWO therapysystem. The controller may be configured to analyze data from theassessment system and show the data on the display. The apparatus mayfurther comprise a nebulizer coupled to a pressurized air source carriedby the housing. The pressurized air source may be a compressor.

The apparatus may include a housing and an air pulse generator operableto deliver a HFCWO therapy to a patient. The air pulse generator mayhave a first pressure source carried by the housing and a secondpressure source carried by the housing. The second pressure source maybe configured to be coupled to a nebulizer. The first pressure sourcemay comprise a blower. The second pressure source may comprise acompressor. Additionally or alternatively, the second pressure sourcemay comprise a vacuum source carried by the housing and configured to becoupled to a suction therapy device. The pressure source and/or vacuumsource may be coupled to a port located on a wall of the housing. Thesource may supply pressurized air and vacuum to the port in first andsecond modes of operation, respectively. The source may supplypressurized air and then vacuum to the port so as to produce a coughassist to a patient.

The HFCWO therapy system may be used with a plurality of patients. Thesystem may comprise an air pulse generator operable to produceoscillating pressure that is applied to a patient, a controller operableto control the operation of the air pulse generator in accordance with aset of operating parameters, a memory for storing the operatingparameters for each of the plurality of patients, and a user interfaceapparatus usable to select one of the patients from the plurality ofpatients for whom the system is used. The controller may be configuredto automatically operate the air pulse generator in accordance with theoperating parameters associated with the selected patient.

The user interface apparatus may comprise a display. The display may besignaled by the controller to display a plurality of user interfacescreens. One of the plurality of user interface screens may be a homescreen having a plurality of icons. Each icon may be associated with arespective one of the plurality of user interface screens. The pluralityof icons may include one or more of a patient icon, a spirometry icon, avest-and-spirometry icon, a vest program icon, a data download icon, anda help icon. Selection of any of the plurality of icons results in anassociated screen being displayed on the display.

The HFCWO therapy system may comprise a garment, such as a wrap or avest, having a double fabric layer providing at least one inflatablebladder, or between which at least one inflatable bladder is situated. Apair of hoses may be routed through associated slits in the wrap toestablish fluid communication with the bladder. In some embodiments, agarment for HFCWO therapy may comprise a mesh fabric layer and at leastone inflatable bladder. In some garment embodiments, a layer facing thepatient may be a low air loss layer having a plurality of perforationsthrough which air is expelled toward the patient to enhance cooling ofthe patient and/or to enhance evaporation of perspiration. In someembodiments, the garment is couplable to a sheet under a patient via oneor more couplers. The couplers may comprise one or more garters eachhaving a strap coupled to the garment and having a clip that releasablycouples to the sheet. An inner layer of material of the garment may be awicking material that wicks moisture away from the patient. The garmentmay have at least one cooling fluid channel configured to receive acooling fluid therein to cool the patient during HFCWO therapy.

A garment to be worn by a patient during high frequency chest walloscillation (HFCWO) therapy may be made at least, in part, from clinicalcamouflage material and may have at least one inflatable bladder. Theclinical camouflage material may be impregnated with activated charcoal.Alternatively or additionally, the clinical camouflage material may beimpregnated with an antimicrobial.

A garment to be worn by a patient during high frequency chest walloscillation (HFCWO) therapy may comprise a front panel configured tocover a front of a patient's chest and having at least one inflatablebladder. A right strap may be coupled at two locations to the frontpanel. The right strap may cooperate with the front panel to form afirst loop around a patient's right arm. A left strap may be coupled attwo locations to the front panel. The left strap may cooperate with thefront panel to form a second loop around a patient's left arm. In lieuof the right and left straps, the garment may have a neck strap and atorso strap. The neck strap may be coupled at two locations to the frontpanel and may cooperate with the front panel to form a first loop arounda patient's neck. The torso strap may be coupled at two locations to thefront panel and may cooperate with the front panel to form a second looparound a patient's torso.

An apparatus to be worn by a patient during high frequency chest walloscillation (HFCWO) therapy may comprise a garment having a plurality ofair chambers and a plurality of flow regulators carried by the garment.The garment may cover at least a portion of a patient's chest. The flowregulators may be openable to permit pressurized air to reach anassociated one of the plurality of air chambers and the flow regulatorsmay be closeable to block pressurized air from reaching the associatedone of the plurality of air chambers.

The flow regulators may each have a knob which is accessible on theexterior of the garment to open and close the associated one of theplurality of air chambers. One or more of the plurality of air chambersmay have a cut-out to accommodate a portion of an associated one of theknobs. The plurality of air chambers may comprise side-by-side pairs offirst and second air chambers and each of the first air chambers may besituated vertically above an associated one of the second air chambers.The flow regulators may include a pair of side-by-side valves and eachof the side-by-side valves may be located in a space between theassociated first and second air chambers. When each of the side-by-sidevalves are opened, the first and second air chambers may be in fluidcommunication and when each of the side-by-side valves are closed, thefluid communication between the first and second air chambers may beblocked. The plurality of air chambers may further comprise aside-by-side pair of third air chambers and each of the third airchambers may be situated vertically below an associated one of thesecond air chambers. The flow regulators may comprise an additional pairof side-by-side valves which may be located in a space between theassociated second and third air chambers.

Each of the first air chambers have a first volume that may be largerthan a second volume of each of the second air chambers and the secondvolume may be larger than a third volume of each of the third airchambers. The garment may be openable and closeable along a split linethat extends generally vertically between the side-by-side pairs offirst, second, and third air chambers.

The garment may further comprise a hose interconnecting a first airchamber of the plurality of air chambers and a second air chamber of theplurality of air chambers. The plurality of flow regulators may comprisea hose clamp coupled to the hose. The hose clamp may be accessible to bemanipulated to open and close the hose. The first air chamber to whichthe hose is coupled may be located above the second air chamber to whichthe hose is coupled.

According to aspects of this disclosure, a system for applying highfrequency chest wall oscillation (HFCWO) therapy to a patient maycomprise a garment that has a plurality of air chambers and that isconfigured to cover at least a portion of the patient's chest. Thesystem may further have an air pulse generator operable to produce afirst oscillating pressure and a second oscillating pressure. The firstoscillating pressure may be communicated to at least a first air chamberof the plurality of air chambers and the second oscillating pressure maybe communicated to at least a second air chamber of the plurality of airchambers.

The air pulse generator may have a first oscillating diaphragm assemblyoperable at a first frequency associated with the first oscillatingpressure and may have a second oscillating diaphragm assembly operableat a second frequency associated with the second oscillating pressure.The system may also have a first blower coupled to the first oscillatingdiaphragm assembly and operable to establish a first baseline pressureassociated with the first oscillating pressure and may further have asecond blower coupled to the second oscillating diaphragm assembly andoperable to establish a second baseline pressure associated with thesecond oscillating pressure.

According to another aspect of this disclosure, a high frequency chestwall oscillation (HFCWO) therapy system may comprise an air pulsegenerator operable to produce an oscillating pressure and a coolantsystem operable to deliver a cooling fluid. The system my furthercomprise a garment configured to be worn by a patient and cover at leasta portion of the patient's chest. The garment may have at least oneinflatable air chamber in communication with the oscillating pressureand at least one channel to receive the cooling fluid.

Additional features, which alone or in combination with any otherfeature(s), such as those listed above and those listed in the appendedclaims, may comprise patentable subject matter and will become apparentto those skilled in the art upon consideration of the following detaileddescription of illustrative embodiments exemplifying the best mode ofcarrying out the embodiments as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a perspective view of a first embodiment of a HFCWO therapysystem showing the HFCWO therapy system supported on a siderail of ahospital bed, a hose supplying pressurized air to the HFCWO therapysystem, and a pair of hoses coupled to the HFCWO therapy system andcoupled to a vest positioned on a patient supported on the bed;

FIG. 2 is a perspective view showing two HFCWO therapy systems, onesupported on a siderail of a hospital bed and one supported on anaccessory rail of a headwall of a patient room;

FIG. 3 is an enlarged perspective view showing the controls of the HFCWOtherapy system of FIG. 1;

FIG. 4 is a block diagram of the HFCWO therapy system of FIGS. 1-3;

FIG. 5 is a perspective view showing a second embodiment of a HFCWOtherapy system in which a housing is supported on a wheeled pedestal,the housing carries a 2-line display screen, a pair of handles, and twoair ports through which high frequency air pulses are routed from theHFCWO therapy system to a garment worn by a patient, and in which thepedestal supports a pair of storage bins having hinged lids;

FIG. 6 is a perspective view, similar to FIG. 5, showing the housingraised to a higher elevation by adjustment of the wheeled pedestal;

FIG. 7 is a perspective view, similar to FIG. 5, showing the lids movedto an opened position to provide access to the storage bins;

FIG. 8 is a perspective view, similar to FIG. 5, showing a remote on/offswitch coupled to the HFCWO therapy system;

FIG. 9 is a screen shot of the display screen showing a manual programmode of the HFCWO therapy system;

FIG. 10 is a screen shot of the display screen showing the status of theHFCWO therapy system;

FIG. 11 is a block diagram of the HFCWO therapy system of FIGS. 5-10;

FIG. 12 is a perspective view of a third embodiment of a HFCWO therapysystem showing a housing supported on a rolling stand, the housinghaving a vertically-adjustable large display, a pair of handles, a lowerstorage compartment, two large air ports through which air pulses arerouted from the HFCWO therapy system to a garment, and a small portthrough which pressurized air is supplied to a respiratory therapydevice, such as a nebulizer;

FIG. 13 is a perspective view, similar to FIG. 12, showing the displayraised to a higher position in which an upper storage compartment isaccessible;

FIG. 14 is a perspective view, similar to FIG. 13, showing a hosecoupled to a pressurized air port in the housing and a mask at the endof the hose;

FIG. 15 is a perspective view, similar to FIG. 14, showing an electronicstethoscope coupled to an input port of the system of FIG. 12;

FIG. 16 is a screen shot of a therapy programs screen that appears on adisplay screen of the display and that has a number of program optionsindicative of different modes of operation of the system;

FIG. 17 is a screen shot of a screen that appears on the display screenwhen the system is in a manual program mode;

FIG. 18 is a screen shot of a home screen of the system of FIGS. 12-15;

FIG. 19 is a block diagram showing an electronic spirometer coupled tothe system of FIG. 12;

FIG. 20 is a screen shot of a screen showing the output of thespirometer of FIG. 19;

FIG. 21 shows a patient holding a mouthpiece in his mouth, themouthpiece being coupled to a nebulizer;

FIG. 22 is a block diagram showing a compressor and a pressurized airreservoir located in the housing of the system of FIG. 12, thepressurized air reservoir supplying pressurized air to the nebulizer ofFIG. 21;

FIG. 23 is a block diagram showing a vacuum pump and a vacuum reservoirlocated in the housing of the system of FIG. 12, the vacuum reservoirsupplying vacuum to a suction device;

FIG. 24 is a perspective view showing a wrap vest having slits in whichtubes may be inserted;

FIG. 25 is a perspective view showing a mesh wrap;

FIG. 26 is a perspective view showing a low air loss wrap;

FIG. 27 is a perspective view showing a wrap with integrated flattubing;

FIG. 28 is a perspective view showing a sheet clamped wrap couplable toa sheet underlying a patient;

FIG. 29 is a perspective view showing a vest having a plurality of airchambers and a set of valves having knobs that are manipulated to openand close associated ones of the air chambers;

FIG. 30 is a perspective view showing a vest having a plurality of airchambers, a set of hose extending between respective air chambers, and aset of hose clamps coupled to respective hoses;

FIG. 31 is partly a perspective view and is partly a diagrammatic viewof a system including a vest having a plurality of air chambers and anair pulse generator that is operable to deliver a first oscillatingpressure to first and second air chambers of the vest and to deliver asecond oscillating pressure to third and fourth air chambers of thevest;

FIG. 32 is a perspective view showing a vest having an inner layer ofmaterial made from a wicking material;

FIG. 33 is a perspective view showing a low air loss vest;

FIG. 34 is a perspective view showing a vest having a plurality of airchambers and cooling channels;

FIG. 35 is a perspective view showing a sheet clamped vest similar tothe wrap shown in FIG. 28;

FIG. 36 is a front perspective view of a garment having a front panel;

FIG. 37 is rear perspective view of the garment of FIG. 36 showing leftand right straps that cooperate with the front panel to form loops thatreceive the patients left and right arms, respectively;

FIG. 38 is a front perspective views showing an apron-like garment;

FIG. 39 is a rear perspective view of the garment of FIG. 37 showing aneck strap and a torso strap;

FIG. 40 is a perspective view showing a vest made from clinicalcamouflage material;

FIG. 41 is a screen shot of a patient screen of the system of FIGS.12-15 showing a list of patients for which operating parameters arestored and showing patient information pertaining to a selected one ofthe patients;

FIG. 42 is a screen shot of a patient edit screen of the system of FIGS.12-15 showing various touchscreen keys which are used to edit thepatient information stored in the system;

FIG. 43 is a screen shot of a spirometry screen of the system of FIGS.12-15 prior to a spirometry test being run by the system;

FIG. 44 is a screen shot of the spirometry screen of the system of FIGS.12-15 after a spirometry test has been run by the system showing tabularand graphical data related to the spirometry test;

FIG. 45 is a screen shot of a vest-and-spirometry screen of the systemof FIGS. 12-15 prior to a vest-and-spirometry test being run by thesystem;

FIG. 46 is a screen shot of the vest-and-spirometry screen of the systemof FIGS. 12-15 after a vest-and-spirometry test has been run by thesystem showing tabular and graphical data related to thevest-and-spirometry test;

FIG. 47 is a screen shot of a vest program screen of the system of FIGS.12-15 having vest mode control buttons which are usable to establishwhich mode is to have the associated parameters programmed;

FIG. 48 is a screen shot of a vest program edit screen of the system ofFIGS. 12-15 showing edit keys on the left side of the screen that areusable to edit the parameters listed on the right side of the screen;

FIG. 49 is a screen shot of a data transmission screen of the system ofFIGS. 12-15 showing buttons on the left side of the screen that areusable to initiate a data transmission from the system to a printer, acomputer, or a portable wireless device;

FIG. 50 is a screen shot of a data transmission confirm screen of thesystem of FIGS. 12-15 showing buttons that are usable to confirm or tocancel the data transmission;

FIG. 51 is a screen shot of a help screen of the system of FIGS. 12-15showing a list of the various portions of the system for whichinformation is stored in the system to assist user to learn about theoperation of the system;

FIG. 52 is a perspective view of another embodiment of a HFCWO therapysystem showing an air pulse generator supported on a shelf of a wheeledpedestal, the wheeled pedestal having a vertically oriented telescopiccolumn, a chart holder coupled to a front of an upper segment of thetelescopic column, hose clips coupled to the sides of the upper segmentof the telescopic column, casters coupled to a set of legs extendingfrom a bottom segment of the telescopic column, a push handle extendingrearwardly from the shelf, and a release handle situated just below aside region of the shelf for unlocking an elevation adjustment mechanismsituated in an interior region of the telescopic column to permit theupper segment of the column to be raised and lowered relative to thelower segment; and

FIG. 53 is a top plan view of the HFCWO therapy system of FIG. 52showing the shelf having a larger footprint than the air pulse generatorsuch that the shelf has portions extending beyond the front, back, andsides of the air pulse generator, and showing one of the sides regionsof the shelf having a notch which opens into a circular aperture whichis sized and configured to receive a mouthpiece or other piece ofauxiliary equipment which is used with the air pulse generator duringHFCWO therapy.

DETAILED DESCRIPTION OF THE DRAWINGS

The term “air” as used in the specification and claims is used broadlyto include regular or ambient air, medical air, nitrogen, oxygen, andany other breathable, as well as non-breathable, gas available in ahospital or healthcare facility. The terms “hospital” and “healthcarefacility” are used interchangeably, and each is intended to broadlyinclude hospitals, healthcare facilities, nursing homes, outpatientclinics, doctors' offices, medical care facilities, and the like. Theterms “respiratory therapy” and “airway clearance therapy” are usedinterchangeably, and each is intended to broadly include a HFCWOtherapy, a positive expiratory pressure (PEP) therapy, a nebulizertherapy, an intermittent positive pressure breathing (IPPB) therapy, acough assist therapy, a suction therapy, a bronchial dilator therapy,and the like. The term “vacuum” as used in the specification and claimsis used broadly to include negative pressures or pressures belowatmospheric pressure.

FIGS. 1-4 illustrate a first embodiment 100 of a HFCWO therapy systemaccording to this disclosure. As shown in FIG. 1, the HFCWO therapysystem 100 is supported on a siderail 102 of a hospital bed 104. Thesystem 100 generates HFCWO air pulses for application to an inflatablevest 106 positioned on a patient 108. The system 100 includes a housing110 having a pair of air ports 112. The vest 106 includes an inflatablebladder 114 having a pair of air ports 116. A pair of hoses 118 arereleasably coupled to the ports 112 of the housing 110 and the ports 116of the bladder 114. The air pulses are routed from the system 100 to thevest 106 via the hoses 118. U.S. Pat. No. 6,916,298, which is herebyincorporated by reference herein, discloses an illustrative HFCWOtherapy vest which may be coupled to system 100 in lieu of illustrativevest 106. In addition, any of the garments disclosed herein and shown inFIGS. 24-40 may be used with system 100, if desired.

As shown in FIG. 4, the system 100 includes an air pulse generator 120which is located in an interior region of the housing 110. The air pulsegenerator 120 is operable to produce the HFCWO air pulses. The air pulsegenerator 120 includes a self-oscillating valve 122 coupled via a hose126 to a source of pressurized air, such as a hospital pressurized airsystem which includes one or more outlets 124 that are located inhospital rooms to provide connection points to the pressurized airsystem. The hose 126 is also coupled to a port 128 of the housing 110.Illustratively, port 128 is provided on the bottom of housing 110, butmay be provided on some other part of housing 110, such as the back,front, top, or one of the sides of the housing 110, if desired. The airpulse generator 120 includes an air amplifier 130 coupled to theself-oscillating valve 122 and coupled to the bladder 114 of the vest106 via a pair of hoses 118. In other embodiments, system 100 may haveonly a single hose 118 or may have more than two hoses 118, if desired.Various hose segments or other conduits that extend from housing 110 tovest 106 are considered to be a “hose” according to this disclosure.

The self-oscillating valve 122 is driven by pressurized air from thepressurized air outlet 124 to produce oscillating pressure comprisingfirst pressure pulses having a first pressure and a first volume flowrate for application to the air amplifier 130. The air amplifier 130converts the first pressure pulses into oscillating pressure comprisingsecond pressure pulses that are communicated to the bladder 114. Thesecond pressure pulses have a second pressure that is smaller than thefirst pressure and have a second volume flow rate that is greater thanthe first volume flow rate.

The self-oscillating valve 122 includes a pair of proportioning valves132, shown diagrammatically in FIG. 4, which are coupled to a pressurecontrol 134 and a frequency control 136 which are mounted on the housing110 as shown in FIGS. 1-3. The pressure control 134 is operable to varya base line pressure or steady state pressure about which the air pulsesoscillate and the frequency control 136 is operable to vary thefrequency of the air pulses. In the illustrative system 100, controls134, 136 comprise knobs that are rotated or turned to adjust the amountby which the respective valves 132 are opened or closed. In thediagrammatic view of FIG. 4, hose 124 splits into two segments thatcouple to respective valves 132. In other embodiments, hose 126 couplesto an inlet of a manifold that provides flow paths from the inlet to twooutlets which are, in turn, coupled to the valves 132 of valve 122. Instill other embodiments, hose 126 may couple to valve 122 and valve 122may include flow passages that direct air from hose 126 to valves 132.

Valve 122 further includes a valve member 131, shown diagrammatically inFIG. 4, which moves back and forth within a valve chamber at a frequencydictated by the position of control 136. The base line pressure orsteady state pressure of the oscillating pressure which is communicatedthrough the valve chamber to air amplifier 130 is dictated by theposition of control 134 as mentioned above. Valve 122 includes a valvebody 133 which defines the valve chamber in which valve member 131reciprocates. The valve body 133 may comprise one or more pieces ofmaterial and typically will also have a set of flow channels throughwhich pressurized air flows so as to cause the reciprocation of valvemember 131. Some of the set of flow channels communicate with the valvechamber through respective ports. As valve 131 reciprocates within thevalve chamber, various ones of the ports are blocked or opened dependingupon the position of valve member 131 within the chamber. Valve 122 mayalso have cross-over valves and/or check valves or the like to controlthe flow of pressurized air through the various flow channels atdifferent times during the reciprocation of valve member 131 within thevalve chamber of valve body 133.

In one embodiment, the self-oscillating valve 122 is of the typesupplied by J.W.F. Technologies as Numatics Model No. L23PP4520, and theair amplifier 130 is of the type marketed by Pelmar Engineering Ltd. asITW Vortec Model No. 902. While the pressure of the pressurized airsupplied to the self-oscillating valve 122 is dictated by the componentsand configuration of the medical gas system of the associated healthcarefacility, pressures of such systems typically range from about 40 toabout 100 p.s.i. (pounds per square inch) and the air that is suppliedby such systems is usually at a relatively low flow rate, which flowrate is established, at least in part, by the internal components of theassociated outlet 124. The pressure within bladder 114 of vest 106during HFCWO therapy is typically on the order of about 0.1 p.s.i. (oreven less) to about 1.2 p.s.i. (or even more) and the volume flow rateof air during HFCWO may be on the order of about 20 in³ (or less) percycle to about 30 in³ (or more) per cycle. In one embodiment, the volumeflow rate of air is about 29 in³ per cycle. Thus, valve 122 and airamplifier 130 are chosen so as to reduce the incoming pressure fromoutlet 124 down to a suitable pressure range for HFCWO therapy and toincrease the flow rate up to be a suitable volume flow rate range forHFCWO therapy. To achieve the desired results, therefore, embodiments ofsystem 100 having series and/or parallel combinations of two or more airamplifiers 130 are within the scope of this disclosure, as areembodiments having one or more pressure regulators situated in the flowpath between hose 124 and valve 122 and/or situated in the flow pathbetween valve 122 and air amplifier 130 (or amplifiers 130 if more thanone are provided).

In the illustrated embodiment, the frequency of the air pulses appliedto the bladder 114 of vest 106 is adjustable to be from about 0 Hertz(Hz) to about 20 Hz as indicated by the indicia adjacent to control 136shown in FIG. 3. For typical HFCWO therapy, the operational frequency ofsystem 100 is 5 Hz or higher, which is a much higher frequency than thefrequency typically used for cardio pulmonary resuscitation (CPR). Theindicia adjacent to control 134, as shown in FIG. 3, include numerals 1through 10, which numbers are relative settings corresponding generallyto the amount by which the valve 132 associated with control 134 isopened, with a setting of 10 corresponding to fully opened.

The system 100 includes a timer control 138 mounted on the housing 110to provide an alarm signal to indicate that a therapy time selected by apatient or caregiver has ended. In the illustrative embodiment, timercontrol 138 comprises a knob that is turned by a desired amount to set amechanical timer that is carried by housing 110 and that is coupled tocontrol 138. Illustratively, the system 100 uses a rotary spring woundtimer. Thus, the timer controlled by control 138 may be a so-called “eggtimer.” The mechanical timer produces an audible alarm, such as ringinga bell or chime included in the timer, when the therapy time haselapsed.

A hanger 140 is coupled to housing 110 and is configured to suspend thehousing 110 from any suitable support device, such as the siderail 102of the hospital bed 104. Alternatively, the housing 110 may be supportedby an accessory mounting rail 142 of a headwall 144 in a patient room146 of a hospital as shown with respect to the system 100 shown on theright side in FIG. 2. In the illustrative example, hanger 140 is a solidpiece of material that extends rearwardly from the top of housing 110and forms a hook that is configured to catch on the siderail or headwallrail or other similar support structure. In other embodiments, hanger140 may extend from the back of housing 110 at some other location, suchas, for example, midway between the top and bottom of housing 110.

If desired, hanger 140 may be formed integrally with other portions ofhousing 110, such as the top or back of housing 110, rather than being aseparate component that couples to housing 110. It is within the scopeof this disclosure for system 100 to have some other types of hangersfor supporting housing 110 relative to a support device. For example,other hangers may comprise clamps or straps. Furthermore, it is withinthe scope of this disclosure for some or all of hanger 140 to movebetween a storage position, such as a position retracted into oradjacent housing 110 or even a position folded against housing 110, anda use position in which hanger 140 is deployed for use. The housing 110and the hanger 140 are both made of high-strength, light weight plasticin the illustrated embodiment but may be made from any materials havingsuitable strength.

In operation, system 100 produces a pressure having a steady state airpressure component (or “bias line pressure”) and an oscillating airpressure component. The air pulses oscillate the bladder 114, whilekeeping it inflated. The bladder 114 applies an oscillating compressiveforce to the chest of the patient 108. The oscillating compressive forceapplied to the chest has an oscillatory force component and a steadystate force component which respectively correspond to the oscillatingair pressure component and the steady state air pressure component.Illustratively, the steady state air pressure component is greater thanthe atmospheric pressure with the oscillatory air pressure componentriding on the steady state air pressure component. The term “steadystate component” as used herein, including in the claims, is notintended to be limited only to an unchanging pressure havingsubstantially no fluctuations, although such an unchanging pressurewould be an example of a steady state component of the pressure. Due tomany factors, including the fact that a high frequency oscillatorypressure is superimposed on the so-called “steady state component,” the“steady state component,” itself, may fluctuate by some amount but yetstill be considered a “stead state component” within the scope of thisdisclosure.

In the illustrated embodiment, the resulting composite waveform providesoscillation cycles of the bladder 114 that are effective at moving thechest of the patient 108, because at no point in the cycles is thepressure applied to the chest by bladder 114 below atmospheric pressure.It should also be understood that vest 106 has an established leakagerate to permit pressurized air to exhaust from vest 106 to the ambientatmosphere. Depending upon the design of vest 106, such leakage mayoccur through holes created by stitching between layers of material thatdefine bladder 114, through holes created by stitching between a singlelayer and an enclosure that defines bladder 114, through discrete holesformed in one or more layers of vest 106, or through a loose weave ofmaterial forming a part of vest 106. Due to the fact that system 100 hasmoving components (such as the shuttling valve member 131 in theself-oscillating valve 122) and due to the fact that the leakage rate ofpressurized air from vest 106 may not be constant (due to the fact, forexample, that inhalation of the patient may tend to force air out ofvest 106 more so than when the patient is inhaling), it will beappreciated, therefore, that these are additional factors thatcontribute to the steady state pressure or bias line pressure possiblynot being a constant pressure but rather fluctuating within some rangeof pressures. However, such a fluctuating pressure is still consideredto be a steady state pressure or a bias line pressure, according to thisdisclosure, including in the claims as already mentioned.

Based on the foregoing, it will be appreciated that system 100 is anall-pneumatic system without any electrical components, although thetimer is a mechanical timer. The system 100 is couplable to outlet 124and is operably driven by pressurized air from a pressurized gas systemwhich communicates pressurized air to system 100 through the associatedoutlet 124 of a hospital or a healthcare facility. Therefore, system 100does not include a blower or a motor-and-diaphragm assembly, nor doessystem 100 include the attendant electronic circuitry associated withsuch components, thereby reducing the cost of, the weight of, and thespace occupied by, system 100 as compared to prior art HFCWO systems.The system 100 is so compact that the housing 110 of the system 100 canbe supported on a siderail or an accessory mounting rail of a hospitalbed as shown, for example, in FIGS. 1 and 2. For example, the width andthe depth of the housing 110 may be on the order of about 3 inches toabout 9 inches, and the height of the housing 110 be on the order ofabout 6 inches to about 12 inches. In other embodiments, housing 110 mayhave dimensions that are larger than, or smaller than, the above-listeddimensions.

FIGS. 5-11 illustrate a second embodiment 200 of a HFCWO therapy systemaccording to this disclosure. As shown diagrammatically in FIG. 11,system 200 includes an air pulse generator 202 and a controller 204. Theair pulse generator 202 comprises a blower 206 and an air chamberassembly 208. The blower 206 supplies pressurized air to assembly 208and cooperates with assembly 208 to produce HFCWO air pulses that arecommunicated to a vest 210 of system 200. In some embodiments, the airchamber assembly 208 includes an air chamber shell (not shown) whichreceives pressurized air from the blower 206 and a pair of opposeddiaphragm assemblies (not shown) which are reciprocated toward and awayfrom one another by a motor and linkage assembly to produce air pulsesfor application to the vest 210. This type of air pulse generator isincluded in a HFCWO system marketed by Advanced Respiratory, Inc. of St.Paul, Minn. as the Model 104 system and is disclosed in U.S. patentapplication Ser. No. 10/295,782 which published as US Patent ApplicationPublication No. US 2004/0097842 and which is hereby incorporated byreference herein. Thus, while system 100 is driven by pressurized airfrom the hospital pressurized air outlet 124, system 200 has an on-boardblower 206 for supplying pressurized air.

System 200 includes a housing 220 supported on a wheeled pedestal 222 asshown in FIGS. 5-8. The housing 220 includes a top wall 224, a bottomwall 226, a front wall 228, a rear wall 230, and a pair of side walls232, 234. The air pulse generator 202 and the controller 204 are locatedin an interior region of the housing 220. The front wall 228 has a pairof air ports 260. The air ports 260 are coupled to vest 210 by a pair ofhoses 262 as shown diagrammatically in FIG. 11. A user interface 236 iscoupled to the top wall 224 and is coupled to the controller 204. Theuser interface 236 is configured to allow a caregiver to control theoperation of the air pulse generator 202. As shown best in FIGS. 9 and10, the user interface 236 includes a display screen 238 and a keypad240. The keypad 240 has the following buttons: on button 242, off button244, upper left button 246, lower left button 248, upper middle button250, lower middle button 252, upper right button 254, and lower rightbutton 256. The keypad 240 surrounds the display screen 238. Displayscreen 238 is a liquid crystal display (LCD) screen in some embodiments,although interface 236 may have any suitable type of electronic displayscreen according to this disclosure. In some embodiments, display screen238 is a touch screen which includes appropriate areas thereoncorresponding to one or more of buttons 242, 244, 246, 248, 250, 252,254, 256.

In the illustrative embodiment, the on button 242 is located on the leftside of display screen 238 and the off button 244 is located on theright side of display screen 238. The buttons 246, 250 and 254 arelocated above and adjacent to the top of display screen 238 and thebuttons 248, 252 and 256 are located below and adjacent to the bottom ofdisplay screen 238. The caregiver may modify the operation of air pulsegenerator 202 by using the buttons 246, 248, 250, 252, 254, 256. Thefunction of the buttons 246, 248, 250, 252, 254, 256 varies depending onthe current state or mode of the air pulse generator 202. In someembodiments, air pulse generator 202 is operable in any of the modesdescribed in U.S. patent application Ser. No. 10/295,782 which publishedas US Patent Application Publication No. US 2004/0097842 and which isalready incorporated by reference herein. Such modes include, forexample, a manual mode, a step program mode, a sweep program mode, atraining mode, and a custom program mode.

Exemplary information which appears on display screen 238 in the manualmode is shown in FIG. 9. In particular, display screen 238 shows twolines of information. The upper line of information includes the words“Frequency,” “Pressure,” and “Time Set.” The lower line of informationshows the current settings for the corresponding parameter. In theillustrative example, the frequency of system 200 is set for 12 Hz, thepressure setting is 4, and the therapy duration is set for 15 minutes.As was the case with system 100, the pressure number shown on displayscreen 238 in the manual mode is a relative number (e.g., an integerbetween 0 and 10) and not the actual steady state pressure. In otherembodiments, the pressure number shown on display screen 238 may be thesteady state pressure setting (e.g., 0.1 p.s.i. to 1.2 p.s.i.). Thetwo-line display of information on display screen 238 enables system 200to provide more information to a user or caregiver than the one-linedisplay screen included in the prior art Model 104 system mentionedabove.

In the manual mode, buttons 246, 248 may be pressed by a user orcaregiver to increase and decrease, respectively, the frequency settingof system 200; buttons 250, 252 may be pressed by a user or caregiver toincrease and decrease, respectively, the pressure setting of system 200;and buttons 254, 256 may be pressed by a user or caregiver to increaseand decrease, respectively, the time setting of system 200. Once themanual mode parameters are set, the user or caregiver initiates theHFCWO therapy according to the parameters by pressing the on button 242.If the user or caregiver wants to stop the therapy, the user orcaregiver does so by pressing the off button 244. If the user orcaregiver pressure off button 244 when no HFCWO therapy is occurring,then system 200 powers down. If system 200 is powered down, then theuser or caregiver presses the on button 242 to power up the system. Insome embodiments, a remote on/off pendant 266 is coupled to thecontroller 204 by an extension cord 268, as shown in FIG. 8, andincludes on and off buttons which may be used in the same manner as justdescribed regarding the manner in which on and off buttons 242, 244 areused. The on and off buttons of pendant 266 are color coded such thatthe on button is green and the off button is red.

The HFCWO therapy automatically stops when the time duration iscomplete, and a message such as “Session Ended, Therapy Complete” isdisplayed on the display panel 238 as shown in FIG. 10. The displaypanel 238 also provides feedback to the caregiver as to the status ofsystem 200 when requested via appropriate presses of buttons 242, 244,246, 248, 250, 252, 254, 256. For example, pressing two of buttons 242,244, 246, 248, 250, 252, 254, 256 simultaneously may result incorresponding status information being displayed on screen 238 and thetype of information displayed may vary depending which combination oftwo buttons 242, 244, 246, 248, 250, 252, 254, 256 are simultaneouslypressed. The messages are displayed as text on the display panel 238.Also, the caregiver may use the buttons 246, 248, 250, 252, 254, 256 toprogram the air pulse generator 202. In the illustrated embodiment, inaddition to the manual program mode, the caregiver can choose one ofthree pre-set program modes. The three pre-set program modes are storedas software in one or more memory devices included in controller 204.

In addition to display screen 238, buttons 242, 244, 246, 248, 250, 252,254, 256, and one or more memory devices, controller 204 also includesall other electrical components associated with the operation of system200. In one embodiment, controller 204 is substantially the same as thatshown and described in U.S. patent application Ser. No. 10/295,782 whichpublished as US Patent Application Publication No. US 2004/0097842 andwhich is already incorporated by reference herein. Two lines of up to 24characters each are displayable on display screen 238.

As mentioned above, system 200 includes a housing 220 supported on awheeled pedestal 222. A pair of generally C-shaped handles 264 arecoupled to the housing 220 and are gripped by users or caregiver tomaneuver system 200 along a floor. Each handle 264 has one end coupledto front wall 228 and another end coupled to rear wall 230. The handles264 are coupled to walls 228, 230 of housing 220 closer to top wall 224than to bottom wall 226. In addition, each of the handles extend aroundthe sides of housing 220 with a central portion of each handle 264 beingspaced from the respective side wall 232, 234 of housing 220.

The bottom wall 226 of the housing 220 is coupled to the pedestal 222 bya lockable swivel joint (not shown) which is unlockable to permittitling of housing 220 relative to pedestal 222 about a generallyhorizontal axis. This allows the caregiver to tilt the housing 220 tochange the viewing angle of the display screen 238. The pedestal 222 isvertically extendable and retractable to support the housing 220 atselected elevations. The pedestal 222 includes a wheeled base 270, astationary portion 272 coupled to wheeled base 270, and a telescopingportion 274 coupled to the stationary portion 272 and coupled to thebottom wall 226 of the housing 220 by the lockable swivel joint.

In the illustrative example, portions 272, 274 comprise cylindricaltubes with round cross sections, but tubes having other cross sectionssuch as polygonal (e.g., square, rectangular, triangular, hexagonal,etc.) or oval or elliptical or any other desired shape are within thescope of this disclosure. The telescoping portion 274 is movablegenerally vertically relative to the stationary portion 272 between alowered position shown in FIG. 5 and a raised position shown in FIGS.6-8. In some embodiments, the telescoping portion 274 is pivotable abouta generally vertical axis relative to the stationary portion 272.Additionally or alternatively, the lockable swivel joint may beconstructed to permit housing 220 to pivot about a generally verticalaxis relative to pedestal 222.

An elevation adjustment mechanism and/or locking mechanism (not shown),such as a locking gas spring, normally locks the telescoping portion 274in place relative to the stationary portion 272 but is unlockable topermit telescoping movement of portion 274 relative to portion 272. Insome embodiments, one or more release handles or levers are coupled toone or both handles 264 and are movable to release the lockingmechanism. For example, if the locking mechanism is a locking gasspring, then a Bowden wire or cable (e.g., a sheath having a wireextending therethrough) may have one end coupled to the release leverand have another end coupled to a portion of the locking gas spring thatis actuated or moved to release or unlock the locking gas spring. Such aBowden wire may be routed from the release lever, through a portion ofthe corresponding handle 264, through housing 220, and through a portionof pedestal 222. Movement of the release lever, in such embodiments,causes the wire to move within the sheath and unlock the gas spring. Thegas spring, when released, may be of the type that is biased to extendthereby providing an upward force that assists the user or caregiver inmoving housing 220 upwardly.

In other embodiments of system 200, a release lever or handle is coupledto pedestal 222 beneath housing 220 and is movable to unlock and lockthe elevation adjustment mechanism and/or locking mechanism. In stillother embodiments, the elevation adjustment mechanism and/or lockingmechanism may comprise a hydraulic cylinder or a pneumatic cylinder anda foot pedal (not shown) may be coupled to base 270 and movable to raiseand lower the height of the pedestal 222. For example, a repetitivepumping action of such a foot pedal through a stroke length may resultin hydraulic fluid being pumped into the hydraulic cylinder (or airbeing pumped into the pneumatic cylinder) to raise the pedestal 222 anddepressing and holding the foot pedal in its lowest position may resultin hydraulic fluid exiting the hydraulic cylinder (or air exiting thepneumatic cylinder) to lower the pedestal 222.

In further embodiments of system 200, a jack screw arrangement may beprovided in pedestal 222 such that rotation of housing 220 and portion274 in one direction about a generally vertical axis relative to portion272 results in extension of portion 274 relative to portion 272, therebyto lift housing 220 relative to base 270, and rotation of housing 220and portion 274 in an opposite direction relative to portion 272 aboutthe generally vertical axis results in retraction of portion 274relative to portion 274, thereby to lower housing 220 relative to base270. In such embodiments having a jack screw arrangement as theelevation adjustment mechanism, a latch or retractable pin or the likemay be provided to serve as a locking mechanism to prevent rotation ofportion 274 relative to portion 272. Such a pin or latch may be coupledto portion 272 and may have a portion that enters a hole or recessprovided in portion 274 to lock portion 272 from rotating relative toportion 274 and that is withdrawn from the hole or recess to permitrotation of portion 272 relative to portion 274.

In yet other embodiments, an electrically powered linear actuator may beprovided as an elevation adjustment mechanism to raise and lower portion274 relative to portion 272 thereby to raise and lower, respectively,housing 220 relative to base 270. Such a linear actuator may be poweredby a battery carried within housing 220 or on base 270. Alternatively oradditionally, such a linear actuator may be powered by electrical powerreceived from a wall outlet when a power cord (not shown) of system 200is plugged into the outlet. If system 200 has an on-board battery topower the linear actuator, the battery may be recharged when system 200is plugged into a power outlet. In such embodiments, controller 204includes battery recharging circuitry. In further embodiments, a handcranking mechanism may be provided as an elevation adjustment mechanismto extend and retract portion 274 relative to portion 272 thereby toraise and lower, respectively, housing 220 relative to base 270. Such ahand cranking mechanism may include a hand crank coupled to portion 272,a worm gear arrangement coupled to the hand crank, and a rack-and-pinionarrangement coupled to the worm gear arrangement and coupled to portion274. One of the gears of the worm gear arrangement may be the pinion ofthe rack-and-pinion arrangement, with the rack being coupled to portion274 to raise and lower therewith as the hand crank turns a worm of theworm gear arrangement which meshes with the pinion.

A pair of storage bins 276 are coupled to the stationary portion 272 ofpedestal 22 on opposite sides thereof. A lid 278 is coupled to each bin276 by a suitable hinge mechanism, such as a living hinge, one or moreflexible straps, one or more pivot pins, or the like. Each lid 278 ismovable relative to the associated bin 276 between a closed positionblocking access to a storage compartment of the respective bin 276 andan opened position allowing access to the storage compartment through anopen top of the associated bin 276. In the illustrated embodiment, thelids 278 are opaque and bins 276 are semi-transparent or substantiallytransparent. In some embodiments, the lids 278 are semi-transparent orsubstantially transparent. The storage compartments of bins 276 providespaces for receipt of other parts of system 200 such as garments (suchas vests or wraps), hoses, mouthpieces, masks, sputum bowls, electricalcords, and equipment for other respiratory therapies, such as a positiveexpiratory pressure (PEP) therapy, a nebulizer therapy, an intermittentpositive pressure breathing (IPPB) therapy, a cough assist therapyand/or other types of a suction therapy such as negative wound pressuretherapy, a bronchial dilator therapy, and the like. While theillustrative system 200 has two bins 276 coupled to pedestal 222,systems having more or less than two bins 276, including systems havingno bins at all, are within the scope of this disclosure.

The whereabouts of system 200 in a healthcare facility may be tracked bya locating-and-tracking system. Thus, a locating-and-tracking badge maybe coupled to the exterior of housing 220 or pedestal 222. Such alocating-and-tracking badge includes a transmitter to transmit awireless signal, either periodically or in response to receipt by areceiver of the badge of a wireless query signal. The wireless signaltransmitted by the badge is received by one or more receivers locatedthroughout the healthcare facility. The transmitter and receiver of thelocating-and-tracking badge may be combined as a transceiver in someembodiments and may be separate in other embodiments. The wirelesssignals includes a unique ID which is associated with system 200.

In other embodiments, the circuitry of system 200 includes a transmitterand/or receiver and/or transceiver to transmit ID data to other portionsof the locating-and-tracking system, either periodically or in responseto a query signal. In such embodiments, therefore, alocating-and-tracking badge does not need to be coupled to the housing220 or pedestal 222. Also in such embodiments, the ID data transmittedby the circuitry of system 200 may be programmable via appropriatepresses of buttons 242, 244, 246, 248, 250, 252, 254, 256 to placesystem 200 into an ID programming mode in which the ID data to betransmitted can be programmed. In addition to the ID data, system 200may transmit data indicative of whether or not system 200 is currentlyin use and optionally, may also transmit data indicative of the amounttime left before the current HFCWO therapy session will end. Thus, acaregiver viewing a remote display screen of a computer of thelocating-and-tracking system can receive information regarding thewhereabouts of a particular system 200 in the healthcare facility. Ifthe information on the display screen of the computer of thelocating-and-tracking system indicates that the system 200 is in use andwill remain in use for some period of time, such as 30 minutes forexample, then the caregiver can avoid retrieving the system 200 for useby another patient until the use by the current patient has finished.

FIGS. 12-23 show a third embodiment 300 of a HFCWO therapy systemaccording to this disclosure. System 300 includes a generally box-shapedhousing 302 having a lower portion 304 and an upper portion 306 as shownin FIG. 12. The lower portion 304 is supported on wheels 308 that arerotatably coupled to respective arms 309 that extend outwardly andslightly downwardly from the sides of lower portion 304 of housing 302.The front arms 309 also extend slightly forwardly from the side ofhousing 302 and the rear arms 309 extend slightly rearwardly from theside of housing 302. In some embodiments, the front wheels 308 and/orthe rear wheels 308 are able to swivel about generally vertical axes tofacilitate turning of system 300 as it is transported along a floor.

The depth from front-to-rear of a lower part of lower portion 304 islarger than the depth of an upper part of lower portion 304 and thedepth of upper portion 306 of housing 302. However, the width from sideto side of housing 302 is generally uniform along the height of housing302. Thus, housing 302 is an upright, generally rectangular structurewhen viewed from the front. Many of the heavier internal components ofsystem 300, such as motors, diaphragm assemblies, compressors, and otherhardware (described in more detail below) are situated in the lower partof portion 304 so that system 300 has a relatively low center of gravitywhich enhances the stability of system 300 and reduces the tendency ofsystem 300 to tip. The wide wheelbase created due to the fact that arms309 support wheels 308 laterally out to the sides of housing 302 andalso slightly forwardly of, and slightly rearwardly of, housing 302 alsoenhances the stability of system 300.

The lower portion 304 of housing 302 includes a storage compartment 310situated behind a door 312 which is coupled to housing 302 by a suitablehinge mechanism and which is movable between a closed position blockingaccess to compartment 310 and an opened position allowing access tocompartment 310. In the illustrated embodiment, the door 312 issubstantially transparent. In some embodiments, the doors 312 are opaqueor are semi-transparent. A hook-like cantilevered structure 313protrudes into compartment 310 from a generally vertical wall 315 whichdefines the back of compartment 310. Structure 313 supports hoses 317 ina looped or coiled configuration as shown in FIGS. 12-15. A verticalfront plate of structure 313 retains hoses 317 on a portion of structure313 on which the coiled hoses 317 hang to prevent hoses 317 from fallingoff of structure 313. If desired, other equipment or accessories, suchas garments of system 300 may be stored in compartment 310.

As shown in FIGS. 13-15, the upper portion 306 of housing 302 includes astorage compartment 314. In the illustrative embodiment, a verticalpartition 319 and a horizontal shelf 321 are provided within compartment314 to subdivide compartment 314 into multiple storage spaces. Similarpartitions and shelves may be provided in space 310, if desired. Inother embodiments, partition 319 and shelf 321 are omitted andcompartment 321 comprises a single storage space. Compartments 310, 314allow vests, hoses, mouthpieces, masks, sputum bowls, electrical cords,and other equipment associated with HFCWO therapy devices and/oradditional respiratory therapy devices and/or assessment systemsincluded in system 300, as well as any other desired equipment orobjects, to be stored in housing 302 and transported from place to placealong with system 300.

As shown diagrammatically in FIG. 19, system 300 includes an air pulsegenerator 316 comprising a blower (not shown) and an air chamberassembly (not shown), similar to the air pulse generator 202 shown inFIG. 11. In addition, the system 300 includes a controller 318 similarto the controller 204 shown in FIG. 11, except that the controller 318has more features and capabilities as explained in more detail below.The air pulse generator 316 and the controller 318 are located withinthe housing 302. As alluded to above, air pulse generator 316 issituated in the lower part of lower portion 304 of housing 302 in theillustrative embodiment. Controller 318 comprises one or more circuitboards and the associated circuitry which may be located anywhere withinhousing 302 at the option of the system designer, although it may bedesirable to have the heavier circuit components, such as powertransformers and the like, located in the lower part of portion 304along with the heavier hardware components. It may also be desirable forany circuit components that are more sensitive to heating to be situatedon a circuit board that is located in upper portion 306 of housing 302away from the motors and motorized components situated in lower portion304. In some embodiments, system 300 has an on-board battery which ishoused within, or carried by, the lower part of portion 304.

System 300 includes components operable to provide HFCWO therapy to apatient and also includes components operable to provide additionalrespiratory therapies to a patient and/or components for assessing ofthe various therapy systems of system 300. Examples of additionalrespiratory therapies for which the associated components may beincluded as part of system 300 include a cough assist therapy (FIG. 14),a nebulizer therapy (FIGS. 21 and 22), a suction therapy, such as coughassist therapy, (FIG. 23), a positive expiratory pressure (PEP) therapy,an intermittent positive pressure breathing (IPPB) therapy, and abronchial dilator therapy. Examples of components of assessment systemswhich may be included as part of system 300 include a flow meter, anelectronic stethoscope 366 (FIG. 15), a spirometer 370 (FIGS. 19 and20), a tympanic thermometer to measure a patient's temperature viainsertion into a patient's ear, a pulse oximeter to measure the patientsblood oxygenation, and a respiration rate monitor to measure thepatients respiration rate. If included, the assessment system of system300 may be operable to determine the efficacy of, and/or to provide datafor determining the efficacy of, at least one of the respiratory therapysystems and/or the HFCWO therapy system of system 300. The equipment anddevices used for these additional therapies and the assessment systemsmay be stored in the storage compartments 310, 314, if desired.

As shown in FIGS. 12-15, the upper portion 306 includes a front wall320, a rear wall 322, a top wall 324, and a pair of side walls 326, 328.A user interface, such as a video monitor or display 330, is coupled tothe front wall 324 for vertical movement between a lowered positionshown in FIG. 12 in which the monitor 330 blocks access to the upperstorage compartment 314 and a raised position shown in FIGS. 13-15 inwhich the upper storage compartment is accessible. The height of themonitor 330 relative to housing 302 is adjustable to suit thecaregiver's convenience. In the illustrated embodiment, the monitor 330includes a touch screen display panel 332. Controller 318 is coupled tomonitor 330 and is operable to cause various screens and various data toappear on the electronic display screen of display 330 as will bedescribed in further detail below. The monitor 330 allows the caregiverto control the operation of the air pulse generator 316 and theoperation of any of the additional respiratory therapy system(s) and/orassessment system(s) included in system 300.

The front wall 320 has a pair of air ports 334 which are configured tobe coupled to a HFCWO therapy vest via hoses 317. Above air ports 334 isa recess in housing 302 that accommodates display 330 therein forvertical upward and downward movement. The recess in housing 302 anddisplay 330 are sized such that a front surface of display 330 isgenerally coplanar with front wall 320 of housing 302. Display 330comprises a flat screen display, such a liquid crystal display (LCD), ofrelatively narrow depth. The depth of display may be on the order ofabout 1 inch (2.54 cm) or less to about 3 inches (7.62 cm) or more. Therecess in housing 302 to accommodate display 330, therefore, has a depththat is substantially smaller than the depth of storage compartment 314as shown in FIGS. 13-15. The depth or the storage compartment may be onthe order of two times or three times or four times or even more thanthe depth of the recess in which display 330 is received. The display330 includes an electronic display screen 332, such as an LCD screen, ahousing which carries the electronic display screen 332, and theassociated electrical components situated in the housing.

The interface between the sides of display 330 and housing 302 mayinclude suitable guide mechanisms to guide the upward and downwardmovement of display 330. For example, each of the sides of display 330may be formed with a vertically oriented rail or tongue which isreceived in a respective vertically oriented groove formed in housing302. Such a rail and groove arrangement may be reversed such that thesides of the display 330 are formed with grooves and the housing 302 isformed with tongues or rails that are received in the grooves of thedisplay 330. In addition, separate members having the rails or tonguesand the grooves may be coupled to housing 302 and display 330 in lieu ofthese guide structures being formed in the sides of display 330 and thehousing 302. In other embodiments, a guide mechanism may include one ormore vertical posts or struts extending downwardly from the bottom ofdisplay 330 into a respective vertically oriented socket provided inhousing 302 beneath display 330. Such a vertically oriented socket maybe situated, in part, between ports 334 or outboard of ports 334. Thevertical partition 319 in such an embodiment may be located so as to besituated behind the vertically oriented post when display 330 is raisedso as to reduce the amount by which the vertically oriented post mayblock or interfere with access to the usable space of storagecompartment 314.

In some embodiments, display 330 and/or housing 302 and/or the guidemechanism itself may have suitable locking mechanisms to lock display330 in place at selected elevations relative to housing 330. Such alocking mechanism may comprise, for example, one or more pins or latchescarried by display which are received in apertures or recesses inhousing 302, or vice versa. The apertures or recesses may be verticallyspaced to define a set of vertical positions in which display 330 may belocked by receipt of the pins or latches in the associated apertures orrecesses. Such pins or latches may be spring biased outwardly relativeto display 330 toward housing 302 and into the apertures or recessesaligned therewith. A release mechanism, such as a lever, knob, or handlemay be provided on display 330 in such embodiments for retracting thepins or latches out of the apertures or recesses to unlock the display330 for movement relative to housing 302. If the pins or latches arecoupled to housing 302 and if the display 330 has the apertures orrecesses, then the release mechanism may be coupled to housing 302.

In embodiments having one or more vertically oriented guide posts, aspring clutch mechanism, such as Mechlok® mechanism available fromPorter Group, LLC of Novi, Mich., may be situated inside housing 302 andcoupled to the vertical guide post. Such a spring clutch mechanismtypically has a rod that is movable relative to a rod housing and aspring that constricts around the rod to prevent the rod from movingrelative to the rod housing. A release mechanism, such as a lever, knob,or handle, may be provided either on display 330 or on housing 302 formanipulation to unlock the normally locked spring clutch mechanism bycausing the spring to loosen about the rod allowing the rod to moverelative to the rod housing. If the release mechanism is provided on thedisplay, then a suitable linkage mechanism, such as Bowden wire, may berouted from the release mechanism, through the interior of display, andthrough a hollow interior of the vertical guide post. In someembodiments, therefore, one of the rod and the rod housing of a springclutch mechanism is fastened to the vertically oriented guide post andthe other of the rod and the rod housing is fastened to a portion ofhousing 302, such as an internal frame member of housing 302 or a flangeextending from front wall 320 in the interior region of housing 320.

In still other embodiments, one of the sides of display 330 may have asuitable hinge mechanism defining a generally vertical axis about whichdisplay 330 pivots to open and close compartment 314. In furtherembodiments, the bottom of display 330 may have a suitable hingemechanism defining a generally horizontal axis about which displaypivots downwardly to open compartment 314. In such an embodiment inwhich display 330 pivots downwardly about a horizontal hinge axis, oneor more suitable stops may be provided to prevent display from pivotingdownwardly beyond a generally horizontal position in which a back ofdisplay 330 provides a work surface that caregivers may use fortemporary placement of objects or for writing on charts, etc.Alternatively, the top of display 330 may have a suitable hingemechanism defining a generally horizontal axis about which displaypivots upwardly to open compartment 314. In these embodiments in whichdisplay 330 is hinged to housing 302, a lock, pin, or latch may beprovide to retain display 330 in the closed position and a releaselever, knob, or handle may be provided for moving the lock, pin or latchto a position allowing the display to pivot to its opened positions.

In still further embodiments, the top of panel 330 may be coupled to abacking panel by a suitable hinge mechanism for pivoting movement abouta generally horizontal axis relative to the backing panel. In such anembodiment, the backing panel raises and lowers along with display 330to open and close compartment 314. The backing panel is retainedrelative to housing 302 in such embodiments by any of the guidemechanisms described above, such as tongue (or rail) and groovearrangements or vertical guide posts. However, display 330 is permittedto tilt out of the recess of housing 302 so that the electronic displayscreen faces upwardly by some amount, such as 30 degrees or 45 degreesor even up to 90 degrees, to provide more ergonomic viewing and accessto the electronic display screen of display 330 by a caregiver orpatient standing in front of system 300. The hinge mechanism of thisembodiment may have friction between components of the hinge mechanismthat is sufficiently high enough to maintain display 330 in a tiltedorientation relative to the backing panel but not so high as to preventa user from pivoting display 330 relative to the associated backingpanel. Alternatively, a strut or other support member may be providedbetween display 330 and the backing panel to maintain the display 330 inits tilted orientation relative to the backing panel.

Those skilled in the art will appreciate that various linkage mechanismsmay be provided in the above-described embodiments for interconnectingthe pins, latches, or locks, as the case may be, with an associatedrelease mechanism so that movement of the release mechanism results inmovement of the associated pins, latches, or locks. Such linkagemechanisms may comprise Bowden wires (refer to the earlier description)and/or links, sliders, cams, followers, and the like. In addition, itshould be understood that electrical lines, such as wires or cables,including ribbon cables, are routed through or beside theabove-described guide mechanisms or hinge mechanisms to provide anelectrical connection between display 330 and the controller 318 ofsystem 300 situated in housing 302. For example, in embodiments havinggrooves formed in housing 302 and a rail formed on display 330, a slotmay be provided within one of the grooves and the electrical lines mayexit through an opening provided in the associated rail and be routedthrough the slot. In other embodiments, the electrical lines betweencontroller 318 and display 330 may be omitted and display 330 may sendand receive signals wirelessly to and from controller 318.

The front wall 320 of housing 302 of system 300 has an additionalpneumatic port 460 to the left of the air ports 334 as shown best inFIG. 13. Port 460 is couplable to a mouthpiece 452 such as the oneshown, for example, in FIG. 21, or a mask 480 as shown, for example, inFIGS. 14 and 15. Mouthpiece 452 and mask 480 are used with system 300when system 300 performs one or more of the integrated additionaltherapies such as, for example, the nebulizer therapy, the cough assisttherapy, and the PEP therapy, just to name a few. In the illustratedembodiment, suction or negative pressure (sometimes referred to herein,including in the claims, as “vacuum”) may be applied to port 460 bysystem 300 as well, for ultimate application to the mouthpiece 452 ormask 480 coupled to port 460. In addition, the front wall of the housingof display 330 has a pair of input ports 362, 364 just below theelectronic display screen 332.

The input ports 362, 364 are configured to be connected to electronicassessment systems, such as an external flow meter (in those embodimentsin which system 300 does not have an internal flow meter), an electronicstethoscope 366, a spirometer mouthpiece 378, a tympanic thermometer, apulse oximeter, a respiration rate monitor, or the like. In otherembodiments, one or more ports 362, 364 are provided on housing 302instead on the housing of display 330. A pair of C-shaped handles 336are coupled to the side walls 326, 328 of the housing 302 and aregrippable by a caregiver to maneuver system 300 along a floor.Additional ports similar to ports 362, 364, which may dedicated toparticular ones of the various assessment systems, may provided in someembodiments. A remote on/off switch (not shown), similar to switch 266of system 200 described above, is couplable to the controller 318 via aport on the housing 302.

An asset tracking badge (not shown) may be attached to one of the wallsof the housing 302 so that an asset tracking system of the hospital cankeep track of the location of the system 300. Such an asset trackingbadge may be the same or similar to those described above in connectionwith system 200. In other embodiments, the circuitry of system 300includes a transmitter and/or receiver and/or transceiver to transmit IDdata to other portions of the locating-and-tracking system, eitherperiodically or in response to a query signal. In such embodimentshaving locating-and-tracking circuitry integrated into system 300, theID data and/or other data transmitted by such circuitry of system 300may be programmable via appropriate presses of icons or buttons onscreen 332 of display 330. In addition to the ID data, system 300 maytransmit data indicative of whether or not system 300 is currently inuse and optionally, may also transmit data indicative of the amount timeleft before the current HFCWO therapy session and/or other respiratorytherapy session and/or assessment session will end. Thus, a caregiverviewing a remote display screen of a computer of thelocating-and-tracking system can receive information regarding thewhereabouts of a particular system 300 in the healthcare facility aswell as additional information regarding the usage status of the system300.

FIGS. 16, 17 and 20 show examples of user interface screens according toone embodiment of system 300. FIG. 16 is a screen shot of a programselect screen 338 that appears on the display panel 332 when the system300 is in a program select mode. As shown in FIG. 16, the air pulsegenerator 316 has four pre-set program modes, namely, a step programmode, a sweep program mode, a training program mode, and a customprogram mode. The caregiver selects a particular program mode by simplytouching the associated quadrant of the screen 338. For example, thecaregiver selects the step program mode by touching upper left quadrantof the screen 338.

The step and sweep program modes are substantially as described in U.S.Patent Application Publication No. US 2004/0097842 which is alreadyincorporated by reference herein. The training program mode allows thecaregiver to start at a desired starting frequency and intensity for theHFCWO therapy and automatically gradually increase the frequency andintensity over a predetermined period of time or a programmed period oftime to a desired maximum frequency and intensity. This is useful forfrail patients and patients that are not accustomed to HFCWO therapy inorder to help them get accustomed to this type of therapy before usingmore powerful settings. The software for the four pre-set program modesis stored in a memory associated with the controller 318. In the customprogram mode, the caregiver is able to create a special waveform for aparticular patient's therapy. Such a special waveform may be inaccordance with wave type, frequency, pressure, and timing parameters ofthe caregiver's choosing or may be in accordance with a menu of specialwaveforms preprogrammed into system 300. In the illustrative customizeprogram icon on screen 338, one example of a possible custom waveform isshown in which system 300 operates according to a step program for afirst period of time and then changes automatically to a sweep programfor a second period of time.

In addition to the four program modes just described, the air pulsegenerator 316 is operable in a manual program mode. In the manualprogram mode, the caregiver manually sets the air pulse frequency, thebias line pressure and the duration of the HFCWO therapy. FIG. 17 is ascreen shot of a screen 340 that appears on the display panel 332 whenthe system 300 is in the manual program mode. The screen 340 shows threeranges 342, 344, 346 of therapy settings, namely, the frequency of airpulses applied to the vest, the bias line pressure and the duration ofthe HFCWO therapy. The air pulse frequency can be varied between 0 Hz to20 Hz. The current value of the air pulse frequency setting (4, in theillustration shown in FIG. 17) is shown in a box 348 on the right sideof the frequency range 342. A box 352 to right of range 344 shows thecurrent value of the relative bias line pressure setting and a box 356to right of range 346 shows the current value of the duration setting ofthe HFCWO therapy.

The caregiver may change the air pulse frequency by touching and thendragging an arrow icon 350 toward the left side of range 342 to decreasethe air pulse frequency or by touching and then dragging icon 350 towardthe right side of range 342 to increase the air pulse frequency. Thedefault frequency in one embodiment is 12 Hz, although embodimentshaving other default frequencies are within the scope of thisdisclosure. Likewise, the caregiver may vary the relative bias linepressure setting to a value between 0 and 10 by moving an arrow icon 354toward the left side or the right side of the associated range 344. Thedefault bias line pressure is 3, although other bias line pressuredefault values are within the scope of this disclosure. In addition, thecaregiver may vary the duration of the HFCWO therapy between 0 and 20minutes by dragging an arrow icon 358 toward the left side or the rightside of the associated range 346. The default time is 10 minutes. Thetherapy automatically stops when the duration is complete, and a messageis shown on the display panel 332 that that the session has ended andthe therapy is complete. In some embodiments, the number in box 356changes during the HFCWO to show the amount of time left before thetherapy session ends and the arrow icon 358 moves to the left alongrange 346 to show the amount of time left in the therapy session. Insome embodiments, the number in box 356 shows both minutes and seconds,rather than showing just minutes.

Screen 340 has a help button 360 that allows the caregiver to browse theproduct documentation, watch an in-service video, view clinical studiesand claims, view technical literature, view user manuals, and accesstechnical support contact information. All of this information is storedin one or more memory devices included in or associated with controller318 of system 300. Such memory devices may include one or more RAM, ROM,cache memory, or non-volatile memory devices, and the like as well asincluding other types of storage devices such as floppy or removabledisk drives, a direct access storage device (DASD), a hard disk drive, aCD drive, a DVD drive, a tape drive, and the like that are included in,associated with, or coupled to controller 318 and that read data storedon the corresponding type of data storage media (e.g. memory chip,floppy disk, CD, DVD, tape, etc.). Thus, system 300 may comprisemultiple storage devices that are coupled to controller 318, as well ascomprising a portion of the memory of controller 318, such as the memoryof a microcontroller integrated circuit chip. The system 300 also mayinclude one or more reference cards (not shown) that provide a quickreference to the commonly used functionalities of the system 300, suchas, for example, the three pre-set therapy programs, nebulizer therapy,and the use of a spirometer for making a lung assessment of a patient.The reference cards may be configured as pull-out cards and the housing302 may include one or more slots (not shown) for storing thesereference cards.

The system 300 may be integrated with a spirometer, such as thespirometer 370 shown in FIG. 19, for the purpose of making a lungassessment of a patient. The spirometer 370 is configured to measure thelung volume (the volume of air inhaled and exhaled), the flow rate (thedisplacement volume per unit of time) and the lung elasticity of thepatient. A patient lung assessment may be made prior to starting a HFCWOtherapy for a new patient to establish a base line (i.e., the patient'slung volume, flow rate, and lung elasticity prior to a HFCWO therapyregimen and/or prior to a particular HFCWO therapy session) and todetermine optimum settings for the HFCWO therapy for the patient, whichoptimum settings may change from time to time based on the condition ofthe patient. The optimum settings for a HFCWO therapy may include thefrequency of the air pulses applied to the vest, the bias line pressure,and the duration of the HFCWO therapy. In addition, a patient lungassessment may be made periodically during the HFCWO therapy regimen toevaluate a patient's progress.

As shown in FIG. 19, the spirometer 370 includes an interface device 372that is located within the housing 302. The spirometer interface device372 is coupled to the controller 318 of the system 300. In someembodiments, the spirometer interface device 372 has a slot 374 in whicha PCMCIA (Personal Computer Memory Card International Association) card376 is inserted. The card 376 is coupled to a mouthpiece 378 which issituated at least, in part, in the patient's mouth during the spirometrytests or assessments. The card 376 and the slot 374 have complementaryelectrical contacts which mate when card 376 is inserted into slot 374.In addition, the circuitry of interface device 372 adjacent to slot 374and/or card 376 has a transducer 377 for measuring attributes of thepatient's inhalation (also referred to herein as “inspiration”) andexhalation (also referred to herein as “expiration”), such as pressureand/or flow rate. The baseline measurements for a patient (for example,the lung volume, flow rate and lung elasticity) may be made with orwithout the patient undergoing the HFCWO therapy during the spirometrytests. In other embodiments, such as the one shown in FIGS. 12-15, slot374 and card 376 are omitted and the associated spirometer circuitry iscontained within the housing of display 330 and/or within housing 302 ofsystem 300. In such embodiments, an end of a flexible tube 379 extendingfrom mouthpiece 378 is inserted into port 364 to pneumatically couplemouthpiece 378 with the spirometer circuitry, such as to a transducer ofthe type mentioned above.

To make the baseline measurements, the system 300 is turned on, thepatient is seated comfortably in a certain position, the mouthpiece 378is inserted into the patient's mouth, the card 376 is inserted into theslot 374 (or the hose 378 is inserted into port 364), and the patientstarts breathing through his mouth. The patient takes a full breath inand exhales a full breath out. An analog signal representing the flow ofthe patient's breath is converted into digital values by ananalog-to-digital converter included in the interface device 372. Fromthese digital values, application interface (API) software included inthe interface device 372 and/or in controller 318 calculates all thesuccessive flow and volume values. The spirometer output is graphicallydisplayed on the display panel 332. The spirometer 370 may collect datafor two or more of the patient's breaths and then display a waveformcorresponding to the average data for the number of breaths. In someembodiments, the number of breaths for which data is to be collected isprogrammed by a user of system 300.

FIG. 20 is a screen shot of an example of a screen 380 showing a graph381 representing the output of the spirometer 370. In FIG. 20, thex-axis of graph 381 represents the lung volume and the y-axis of graph381 represents the flow rate. The explanation of acronyms used in graph381 is as follows: 1) PEF—peak expiratory flow, 2) FEF₅₀%—forcedexpiratory flow at 50% of expiration, 3) FEF₇₅%—forced expiratory flowat 75% of expiration, and 4) PIF—peak inspiratory flow. Additionalexamples of the spirometer output are shown in FIGS. 44 and 46 foranother embodiment of system 300. If desired, graduated marking showingvolume and flow, with appropriate measurement units, may be provided ongraph 381.

Some other examples of the values that may be calculated by the APIsoftware are: 1) FVC—forced vital capacity, 2) PEFR—peak expiratory flowrate, 3) FEV₀₅—forced expiratory flow volume during first half second,4) FEV₁—forced expiratory flow volume during first second, 5)FEV₃—forced expiratory flow volume during first three seconds, 6)FEV₆—forced expiratory flow volume during first six seconds, 7)FEF₂₅—forced expiratory flow @ 25% of expiration, 8) FEF₅₀—forcedexpiratory flow @ 50% of expiration, 9) FEF₇₅—forced expiratory flow @75% of expiration, 10) FEF₂₅₋₇₅—forced expiratory flow between 25 and75% of expiration (also called MMEF—maximum mid-expiratory flow), 11)FIVC—forced inspiratory vital capacity, 12) PIFR—peak inspiratory flowrate, 13) EV—extrapolated volume, 14) FIV₀₅—forced inspiratory volumeduring first half second, 15) FIV₁—forced inspiratory volume duringfirst second, 16) FIV₃—forced inspiratory volume during first threeseconds, 17) FIF_(0.2-1.2)—forced inspiratory flow between 0.2 and 1.2seconds, 18) FIF₅₀—forced inspiratory flow @ 50% inspiration, and 19)FIF₂₅₋₇₅—forced inspiratory flow between 25 and 75% inspiration.

To determine the optimum settings for the HFCWO therapy for a patient, apatient wearing a HFCWO therapy vest is seated comfortably in a certainposition, the air pulse generator 316 is turned on to apply air pulsesto the vest, the mouthpiece 378 is inserted into the patient's mouth,the card 376 is inserted into the slot 374 (or the hose 379 is insertedinto port 364), and the patient starts breathing through his mouth. Thespirometer 370 converts the patient's breath into digital values whichare processed by the software included in the interface device 372. Thespirometer output is separated into high frequency (greater than 4 Hz inthe illustrated embodiment) and low frequency (less than or equal to 4Hz in the illustrated embodiment) components using software filteringtechniques. The magnitude of the high frequency components is measured.The high frequency components of the output correspond to thesympathetic resonance from the vest seen in the patient's airway. Insome embodiments, the caregiver varies the air pulse frequency and thebias line pressure to maximize the magnitude of the high frequencycomponents. The higher the magnitude of the high frequency componentsthe more effective is the HFCWO therapy. In other embodiments, thesoftware included in system 300 automatically adjusts the air pulsefrequency and the bias line pressure for optimum HFCWO therapy. In suchembodiments, therefore, the system may step up the frequency and/orpressure after each of the patient's breaths (i.e., one cycle ofinspiration and expiration), or after taking the average of the highfrequency spirometry assessment components after two or more of thepatient's breaths, and determine which combination of pressure andfrequency yields the best results for the particular patient. Thespirometer 370 may be of the type marketed by QRS Diagnostic ofPlymouth, Minn.

FIG. 21 shows diagrammatically a nebulizer 450 which may be integratedwith the HFCWO therapy system 300. The nebulizer 450 is coupled to amouthpiece 452 via a nebulizer port 454 as shown in FIG. 21. During thenebulizer therapy, a tube 456 connects the nebulizer 450 to a pressuresource located in the housing 302 of the HFCWO therapy system 300. Inthe embodiment illustrated diagrammatically in FIG. 22, the pressuresource comprises a reservoir 458 that is coupled to the pressurized airport 460 located on the front wall 320 of the housing 302 and that iscoupled to a compressor 462 of system 300. The tube 456 connects thepressurized air port 460 to the nebulizer 450. The compressor 462supplies pressurized air to the reservoir 458. The reservoir 458provides a low airflow to the nebulizer 450 through the tube 456.

The airflow from system 300 aerosolizes a solution, such as a mildbronchial irritant like hypertonic saline, contained in the nebulizer450 and allows the patient to inhale the solution. The solution providesmoisture to facilitate mucus mobilization and may also help to induce acough. The nebulizer therapy may be administered by itself without theHFCWO therapy. Alternatively, the nebulizer therapy may be administeredsimultaneously with the HFCWO therapy to increase sputum inducement. Thenebulizer 450 may be of the type marketed by O-Two Medical TechnologiesInc. In some embodiments, system 300 includes a nebulizer within housing302 to aerosolize a solution prior to the aerosolized solution exitingport 460 and, in such embodiments, the nebulizer 450 coupled tomouthpiece 452 is omitted such that hose 456 couples directly to port454. If desired, a mask 480 may be coupled to port 460 via an associatedhose 482 as shown in FIGS. 14 and 15, in lieu of mouthpiece 452 andplaced over the patient's nose and mouth during an associated therapy,such as nebulizer therapy.

A suitable electronically controlled valve 461 and a pressure sensor 463are coupled to or situated in the pneumatic path between reservoir 458and port 460 as shown diagrammatically in FIG. 22. In some embodiments,valve 461 is a proportional valve that opens and closes by varyingamounts to establish the pressure communicated to nebulizer 450. Sensor463 provides feedback to controller 318 which, in turn, signals valve461 to open and close, as needed, to maintain the pressure communicatedto nebulizer 450 within a tolerance range of a programmed targetpressure. In other embodiments, valve 461 may be a two-position valvethat is either fully opened or fully closed, such as a solenoid valve,and a pressure regulator may be included in the pneumatic path betweenreservoir 458 and port 460 to limit the pressure available to nebulizer450 from system 300. Alternatively or additionally, nebulizer 450 mayinclude its own pressure regulator. A pressure sensor 465 is alsocoupled to reservoir 458 and provides feedback to controller 318regarding the pressure therein. Controller 318 signals compressor 462 tooperate, as needed, to maintain the pressure within reservoir 458 with atolerance range of a programmed target pressure. A pressure relief valve(not shown) may be coupled to reservoir 458 in some embodiments toprevent reservoir 458 from being pressurized beyond a predeterminedmaximum pressure.

In some embodiments, system 300 is also operable to produce negativepressure for use as suction for therapeutic or other purposes. Toadminister suction during therapy, for example, a mouthpiece, similar tomouthpiece 452 may be placed in the patient's mouth or a mask, similarto mask 480 may be placed over the patient's nose and mouth. A tubesimilar to tube 454 connects the mouthpiece to a vacuum source locatedin the housing 302 of the HFCWO therapy system 300. In the embodimentillustrated diagrammatically in FIG. 23, the vacuum source comprises areservoir 470 that is coupled to a vacuum port 472 located on the frontwall 320 of the housing 302 and that is coupled to a vacuum pump 474.The vacuum pump 474 is operable to evacuate air out of reservoir 470thereby to create a negative pressure in reservoir 470.

In the illustrative example, a suitable electronically controlled valve471 and a pressure sensor 473 are coupled to or situated in thepneumatic path between reservoir 470 and port 472 as showndiagrammatically in FIG. 23. As was the case with valve 461, valve 471is a proportional valve that opens and closes by varying amounts toestablish the pressure communicated to port 472. Furthermore, as was thecase with sensor 463, sensor 473 provides feedback to controller 318which, in turn, signals valve 471 to open and close, as needed, tomaintain the pressure communicated to port 472 within a tolerance rangeof a programmed target pressure. In other embodiments, valve 471 may bea two-position valve that is either fully opened or fully closed, suchas a solenoid valve, and a pressure regulator may be included in thepneumatic path between reservoir 458 and port 472 to limit the pressureavailable at port 472 from system 300. A pressure sensor 475 is alsocoupled to reservoir 470 and provides feedback to controller 318regarding the pressure therein. Controller 318 signals vacuum pump 474to operate, as needed, to maintain the negative pressure withinreservoir 470 with a tolerance range of a programmed target pressure. Avacuum relief valve (not shown) may be coupled to reservoir 470 in someembodiments to prevent reservoir 470 from being pressurized below apredetermined minimum pressure.

Additionally or alternatively, reservoir 470 may be coupled to port 460.Thus, in some embodiments, port 460 is coupled to both a positivepressure source and to a negative pressure source. In such embodiments,a Y-type connector or a manifold may be provided between port 460 andthe associated positive and negative pressure sources. If a Y-typeconnector or manifold is provided, then valves 461, 471 and pressuresensors 463, 473 may be coupled to the Y-type connector or manifold, asthe case may be. In the illustrative examples of FIGS. 22 and 23, thepositive pressure source comprises compressor 462 and reservoir 458 andthe negative pressure source comprises vacuum pump 474 and reservoir470. In other embodiments, one or both of reservoirs 458, 470 areomitted such that compressor 462 alone serves as the positive pressuresource and/or such that vacuum pump 474 alone serves as the negativepressure source. Other positive and negative pressures sources, such asblowers, pumps, and compressors of all types are within the scope ofthis disclosure as being included in system 300.

Cough assist therapy is one example of a therapy in which both positivepressure and negative pressure is communicated to a patient from port460. During cough assist therapy, mask 480 (FIG. 14) is usually placedover the patient's nose and mouth, although a mouthpiece, similar tomouthpiece 454 with or without nebulizer 450 may be used in lieu of mask480, if desired. Tube 482 connects the mask 480 to the pressurized airport 460 located on the front wall 320 of the housing 302 as shown inFIG. 14 and as mentioned above. The patient holds the mask 480 againsthis face over his nose and mouth or, in some embodiments, a strap isprovided to hold mask 480 in place on the patient. During cough assisttherapy, pressurized air is forced into the mouth and/or nose of thepatient through the mask 480 and then quickly sucked out to simulate acough. If desired, the cough assist cycle may be repeated several times.The cough assist therapy device may be of the type marketed by J. H.Emerson Co. of Cambridge, Mass. In some embodiments having only acompressor or pump, such as compressor 462 or pump 474, without anassociated reservoir, the direction of operation of a motor of such acompressor or pump may be reversible such that the compressor or pump isconfigured to supply positive pressure to port 460 when operating in afirst direction and to supply negative pressure to port 460 whenoperating in a second, opposite direction.

Alternatively or additionally, system 300 may be integrated with apositive expiratory pressure (PEP) therapy device; an intermittentpositive pressure breathing (IPPB) therapy device of the type marketedby Vortran Medical Technology 1, Inc. of Sacramento, Calif.; acontinuous positive airway pressure (CPAP) therapy device; and/or aBi-level Positive Airway Pressure device which provides two differentlevels of positive airway pressure depending upon whether the patient isinhaling or exhaling. During the administration of any of thesetherapies, the patient either places a mouthpiece in his mouth or placesa mask over his nose and mouth. It should be noted that, in thedescription which follows it is assumed that a mouthpiece is being used.

A tube or hose extends from the mouthpiece associated with the one ormore additional therapies to a port in housing 302 of system 300. Theport for one or more of these additional therapies included in system300 may be one of ports 460, 364 or may be one or more different,additional ports provided in housing 302 and/or in the housing ofdisplay 330. Circuitry associated with the additional one or moretherapies may be included in controller 318 of system 300 or may beprovided as separate circuitry such as, for example, circuitry adjacentto the one or more additional ports to which the mouthpiece couples forthe one or more additional therapies. Such additional circuitry mayinclude one or more sensors for measuring pressure, flow rate, flowvolume, and the like for the associated one or more additionaltherapies. If such separate circuitry is provided for the one or moreadditional respiratory therapies, such circuitry may be electricallycoupled to controller 318 for the exchange of data or control signalstherewith or to receive power therefrom.

The mouthpieces and/or masks used with the additional respiratorytherapies of system 300 may include various valves, knobs, or othercontrols for controlling various aspects of the therapy delivered to thepatient and may include nebulizers. For example, the PEP mouthpiece mayhave a valve which remains fully open during the inspiratory cycle butthat closes partially during expiratory cycle to require the patient totry to force the air out. In some embodiments, the valve of the PEPmouthpiece flutters to cause the patient's lungs to vibrate. Amouthpiece used with IPPB therapy, for example, may have a knob which isused to adjust a valve that controls peak pressure during inspiration,another knob which is used to adjust another valve that controlsresistive pressure during expiration, and yet another control used toadjust the flow rate during inspiration. Such an IPPB mouthpiece mayinclude a nebulizer. Data (date, time, pressure, flow rate, flow volume,etc.) regarding the one or more additional respiratory therapies may beacquired by system 300 for assessment and stored in a memory deviceassociated with the controller and/or the circuitry of the one or moreadditional therapies. Such data is acquired by one or more sensors (flowmeters, pressures sensors, etc.) that are included in system 300, thatare in electrical communication with controller 318 (possibly throughother circuitry associated with the particular therapy) and that are inpneumatic communication with the one or more ports of the associated oneor more additional therapies.

Referring now to FIGS. 18 and 41-51, examples of user interface screens,or portions thereof, according to another embodiment of system 300 areshown. It will be appreciated that system 300 includes software that isstored in one or more memories devices associated with controller 318and that, when executed, causes various user interface screens, such asthe user interface screens shown in FIGS. 18 and 41-51, to be displayedon the touch screen display panel 332 at different times depending uponuser inputs to system 300.

FIG. 18 is a screen shot of a home screen 390 that appears on thedisplay screen 332. Screen 390 is the default screen that is normallyshown on display screen 332. Thus, if other screens discussed herein areshown but a user does not provide any inputs to system 300 during thedisplay of such screens for a predetermined timeout period, or if system300 finishes acquiring data and/or displaying the acquired data for apredetermined timeout period, the system 300 may automatically defaultto displaying home screen 390. On the left side of the home screen 390is a mode change field 392 which includes a home screen icon 394, apatient icon 396, a spirometer icon 398, a vest & spirometer icon 400, avest program icon 402, a data download icon 404, and a help icon 406. Onthe upper right side of the home screen 390 is a value change field 410which includes the following buttons or icons: on button 412, off button414, upper left button 416, lower left button 418, upper middle button420, lower middle button 422, upper right button 424 and lower rightbutton 426. The caregiver may modify the operation of the air pulsegenerator 316 by using the buttons 416, 418, 420, 422, 424, 426. Thefunction of the buttons 416, 418, 420, 422, 424, 426 may vary dependingon the current state or mode of air pulse generator 316 and furthermore,buttons associated with controlling others of the therapies or functionsof system 300 may be displayed in field 410 in lieu of buttons 416, 418,420, 422, 424, 426.

On the lower right side of the home screen 390 is a window 428. A statusfield 430 appears in the window 428 of the home screen 390 in responseto the caregiver selecting the home screen icon 394, or in response tosystem 300 automatically displaying home screen 390. The left side 432of the status field 430 includes a patient ID number, a list of devicesconnected to one or more of the ports of system 300, and the date andthe time that an associated therapy was administered. In the illustratedexample of screen 390, a vest (such as one of those described below),spirometer 370 (FIGS. 19 and 20), and a nebulizer 450 (FIGS. 21 and 22)are coupled to the system 300.

System 300, therefore, includes sensors to detect the coupling of hoses317 to ports 334, to detect the coupling of hose 456 to port 460, and todetect the coupling of hose 379 to port 364 (or insertion of card 376into slot 374). Such sensors provide signals to controller 318, possiblythrough other associated circuitry in some instances, and controller 318then determines the information to be shown on portion 432 of window 428based on the software programming of system 300. In some embodiments,one or more of these sensors comprise switches that are adjacentrespective ports 334, 364, 460 (or slot 374) and that change state (suchas closing to make a contact) in response to insertion of the associatedhose 317, 379, 457 into the corresponding port 334, 364, 460 (orinsertion of card 376 into slot 374). Other sensors, such as proximitysensors including capacitive sensors or Hall effect sensors to sense thepresence of a magnet attached to the end of a hose (or to a card), aswell as force sensors such as strain gages or other resistive sensorsthat sense insertion of a hose into a port (or a card into a slot), oreven electrical leads that have an electrical path closed due toinsertion of a hose into a port (or a card into a slot), are within thescope of this disclosure for inclusion in system 300 to detect thecoupling of hoses 317, 379, 457 to ports 334, 364, 460 (or insertion ofcard 376 into slot 374). Additional sensors associated with other portsof systems, such as port 362 to which an electronic stethoscope iscouplable as discussed above and any ports associated with additionalrespiratory therapies included in system 300 as discussed above, arecontemplated by this disclosure.

The lower right side 434 of the status field 430 shows an indication ofwhich of the devices connected to the system 300 are on or enabled orcurrently being used. Thus, controller 318 monitors when air pulsegenerator 316 is operating and sensors adjacent to ports 364, 460 detectwhether a patient is breathing though an associated mouthpiece or maskand/or whether positive or negative pressurized air is being deliveredthrough an associated port 364, 460 and controller 318 then determinesthe information to be shown on portion 434 of window 428 based on thesoftware programming of system 300. The upper right side 436 of thestatus field 430 shows tabular, numerical, and/or graphical dataindicative of the operation and/or the output of one or more of thetherapy devices of system 300. In the illustrated example of portion 434of screen 390, the spirometer 370 is on, while the vest (e.g., the airpulse generator 316) and the nebulizer 450 are off. Also in theillustrative example, portion 436 has displayed therein a graph of dataassociated with the HFCWO therapy of system 300. In some embodiments,the data shown on portion 436 of window 428 is selectable by touchingthe associated operating mode description (e.g., “vest,” “neb,” and“spiro”) on portion 434 of window 428.

User interface screens shown in FIGS. 41, 43, 45, 47, 49, and 51 appearin the window 428 of the home screen 390 in response to the caregiverselecting the associated icon 396, 398, 400, 402, 404, 406,respectively. In some embodiments, the mode change field 392 and thevalue change field 410 continue to be displayed on the left side and theupper right side of the home screen 390 regardless of which one of theicons 394, 396, 398, 400, 402, 404, 406 is selected by the caregiver. Inother embodiments, fields 392, 410 may change depending upon theparticular respiratory therapy associated with the information beingdisplayed in window 428.

FIG. 41 is a screen shot of a patient screen 700 that appears in window428 in response to the patient icon 396 being selected. On the left sideof the patient screen 700 is a patient list 702, which lists the patientID numbers of the patients for which system 300 is used to delivery oneor more therapies. When a particular patient is selected by using scrollup and scroll down buttons 704, 706 in the lower left corner of thescreen 700, information concerning the selected patient appears in a setof text boxes in a patient information field 708 on the right side ofthe screen 700. In the illustrated embodiment, the text boxes of thepatient information includes the patient ID number, date of birth,weight, height, race, and an indication of whether the patient smokesand, if he does, how long.

The lower right hand corner of the patient screen 700 includes an editbutton 710 located between the scroll up and scroll down buttons 704,706 as shown in FIG. 41. Once a patient is selected on list 702, thehome icon 394 may be touched, or some other icon 396, 398, 400, 402,404, 406 touched, to display other information in window 728. Inresponse to the selection of a particular patient on list 702 andselecting another icon 394, 396, 398, 400, 402, 404, and 406, system 300is automatically configured to operate according to the settingsprogrammed into system 300, either manually or via a previousassessment, for the particular patient so selected. Thus, in the case ofHFCWO therapy, for example, selection of a patient on screen 702 resultsin system 300 being configured to operate according to the frequency,pressure, and duration programmed previously into system 300. Thus, thecaregiver does not need to reconfigure system 300 for each particularpatient each time system 300 is used with any particular patient. Inthis way, system settings which produce good therapeutic results, oreven optimum therapeutic results, for each of the various patient withwhich system 300 is used, are stored in one or more of the memorydevices associated with controller 318 for later recall by system 300.This saves valuable caregiver time in setting up system 300 for deliveryof the HFCWO therapy or other therapies to the associated patients. Inaddition, data about prior therapy sessions for the particular patientis accessible for viewing on screen 332 once a patient has been selectedin this manner.

FIG. 42 is a screen shot of a patient edit screen 720 that appears onthe display panel 332 in response to edit button 710 on the patientscreen 700 being selected. A patient information field 722, whichcorresponds to the patient information field 708, is located on theright side of the screen 720. The patient ID number in the patientinformation field 722 is grayed out since the particular patient's datais the data to be edited. The left side of the screen 720 includes aplurality of numerical keys 724 for editing the patient information.Also included on the left side of the screen 720 are a scroll down key726 and back and forward space keys 728, 730. The scroll down key 726 isused to select the patient information that is to be edited. Thus,successive presses or touches of icon 726 causes successive text boxesin field 722 to become highlighted, selected, or activated, for editing.Once a particular text box is selected for editing, presses of keys 724,728, 730 change the information in the selected text box. Located in thelower right corner of the screen 720 are save and cancel keys 732, 734.Pressing save key 732 causes the patient data in the text boxes of field722 to be saved in memory of system 300 with the changes made thereto,whereas pressing cancel key 734 cancels the changes made to the patientdata in the text boxes of field 722 such that the previous patient dataprior to any of the changes being made is saved in memory of system 300.

FIG. 43 is a screen shot of a spirometry screen 740 that appears in thewindow 428 in response to the spirometer icon 398 being selected. Theupper left side of the screen 740 lists the ID number of the patientundergoing the spirometry test or assessment. The lower left side of thescreens 740 includes a table of various pulmonary function valuesassociated with the spirometry test. The explanation of the acronymsused in FIG. 43 is given below. Located on the lower left side of thescreen 740 is a start test button 742. The spirometry test is startedwhen the button 742 is selected. The right side of the screen 740 isreserved for depicting the graphical output of the spirometer after thespirometry test is completed or during the spirometry test.

FIG. 44 is a screen shot of a spirometry screen 750 that appears inwindow 428 after the spirometry test is completed. The upper left sideof the screen 750 lists the ID number of the patient that underwent thespirometry test. The lower left side of the screen 750 depicts variouspulmonary function values, the explanation of which appears below. Theright side of the screen 750 depicts the graphical output of thespirometer. Located on the lower right side of the screen 750 are saveand cancel keys 752, 754. Key 752 is pressed to store the results of thespirometry test in one or more of the memory devices associated withcontroller 318. Key 754 is pressed to delete the results of the test andnot store them. The explanation of the acronyms used in FIGS. 43 and 44is as follows: PEF (peak expiratory flow), FEV₁ (forced expiratory flowvolume during first second), FEV₃ (forced expiratory flow volume duringfirst three seconds), FEF₂₅₋₇₅ (forced expiratory flow between 25% and75% of expiration), PIF (peak inspiratory flow), FVC (forced vitalcapacity), FEV₀₅ (forced expiratory flow volume during first halfsecond, and FFF (forced . . . flow).

FIG. 45 is a screen shot of a vest & spirometry screen 760 that appearsin the window 428 in response to the vest & spirometer icon 400 beingselected. During the vest & spirometry test, the spirometry measurementsare made while the patient is undergoing the HFCWO therapy of system300. The upper left side of the screen 760 lists the ID number of thepatient undergoing the vest & spirometry test. The lower left side ofthe screen 740 is reserved for pulmonary volume values—namely, the vestvolume, the breath volume and total volume. Located on the lower leftside of the screen 760 is a start test button 762. The vest & spirometrytest is started when the button 762 is selected. The right side of thescreen 760 is reserved for depicting the graphical output of thespirometer when the vest & spirometry test is completed.

FIG. 46 is a screen shot of a vest & spirometry screen 770 that appearsin window 428 when the vest & spirometry test is completed. The upperleft side of the screen 770 lists the ID number of the patient thatunderwent the spirometry test during HFCWO therapy. The lower left sideof the screen 770 depicts the vest volume, the breath volume and totalvolume. The “vest” volume is the volume of the patient's inspiration andexpiration attributable to the forces applied to the patient by theHFCWO therapy portion of system 300 and the “breath” volume is thevolume of the patient's inspiration and expiration attributable to thepatient's normal breathing during the HFCWO therapy. The total volume isthe sum of the “vest” volume and the “breath” volume. Thus, controller318 of system has software which is programmed to determine the vest,breath, and total volumes based on the data acquired by the spirometerincluded in system 300.

The right side of the screen 770 includes a graph 771 which graphicallydepicts the breath volume data as shown in FIG. 46. In the illustrativeexample, a first sinusoidal-like tracing is superimposed on a secondsinusoidal-like tracing, with the first tracing having higher peaks andlower valleys than the second tracing. The first tracing, therefore,represents the total inhalation and expiration and the second tracingrepresents the patient's normal breathing. Thus, the difference betweenthe first tracing and the second tracing represents the volume ofinspiration and expiration attributable to the HFCWO therapy deliveredto the patient by system 300. The volume totals on the left side of thescreen 770 are determined by integrating some or all of the area underthe first and second tracings (although, the absolute value of theintegral of the portions of the first and second tracings below thex-axis may be used so as to be additive to the integral of the portionsof the first and second tracings above the x-axis). Located on the lowerright side of the screen 770 are save and cancel keys 772, 774. Key 772is pressed to store the results of the vest & spirometry test in one ormore of the memory devices associated with controller 318. Key 774 ispressed to delete the results of the vest & spirometry test and notstore them.

FIG. 47 is a screen shot of a vest program screen 780 that appears inthe window 428 in response to the vest program icon 402 being selected.As shown in FIG. 47, in the second embodiment of the user interfacesoftware, the air pulse generator 316 has three pre-set program modes,namely, a normal program mode, a training program mode, and a customprogram mode. In addition to the three pre-set program modes, the airpulse generator 316 is operable in a manual program mode by using thebuttons 412, 414, 416, 418, 420, 422, 424, 426 which appear in field 410of home screen 390, for example. Buttons 412, 414, 416, 418, 420, 422,424, 426 are used to control the HFCWO therapy of system 300 insubstantially the same manner as buttons 242, 244, 246, 248, 250, 252,254, 256 are used to control the HFCWO therapy of system 200. Thus,button 412 is pressed to turn on the HFCWO therapy of system 300; button414 is pressed to turn off the HFCWO therapy; buttons 416, 418 arepressed to increase and decrease, respectively, the frequency of theHFCWO therapy of system 300 in the manual mode; buttons 420, 422 arepressed to increase and decrease, respectively, the baseline pressure ofthe HFCWO therapy of system 300 in the manual mode; and buttons 424, 426are pressed to increase and decrease, respectively, the duration of theHFCWO therapy of system 300 in the manual mode.

The upper left side of the screen 780 lists the ID number of the patientwhose HFCWO therapy parameters or settings (i.e., the frequency,pressure and time) are being programmed as shown in FIG. 47. Located onthe lower left side of the screen 780 is an air pulse generator modecontrol field 782, which includes a normal program mode button 784, atraining program mode button 786 and a custom program mode button 788.Listed on the upper right side of the screen 780 are text boxes in whichair pulse generator settings, namely, initial frequency, endingfrequency, initial pressure, ending pressure, ramp time, and total time,are shown. Located on the lower right side of the screen 780 are editand start buttons 790, 792. The HFCWO therapy starts when the startbutton 792 is selected.

In the normal program mode of system 300, the air pulse frequency andthe bias line pressure are preset and these values, once set, will bethe default values for the manual program mode of the HFCWO therapy.Accordingly, unless a caregiver or user changes these default values inthe normal program mode, system 300 will return back to these defaultvalues for a particular patient even if buttons 416, 418, 420, 422, 424,426 are manipulated in the manual program mode during a particulartherapy session. In the custom program mode of system 300, the caregivercreates a special waveform for a particular patient's therapy in amanner substantially similar to that described above in connection withthe custom program mode of system 200. Thus, the discussion above of thecustom program mode of system 200 is equally applicable to system 300.The training program mode allows the caregiver to start at a desiredstarting frequency and intensity for the HFCWO therapy and automaticallygradually increase the frequency and intensity (e.g., base linepressure) throughout the duration of the therapy to a desired maximumfrequency and intensity in a manner substantially similar to thatdescribed above in connection with the training program mode of system200. Thus, the discussion above of the custom program mode of system 200is equally applicable to system 300.

FIG. 48 is a screen shot of a vest program edit screen 800 that appearsin window 428 when the edit button 790 on the vest program screen 780 isselected. Listed on the upper right side of the screen 800 in a set oftext boxes are air pulse generator settings, which correspond to the airpulse generator settings on the upper right side of the screen 780.Depending upon which mode button 784, 786, 788 is highlighted orselected at the time that edit button 790 is selected, certain ones ofthe text boxes on screen 800 are grayed and are not editable if they arenot applicable to the mode associated with the selected button 784, 786,788. For example, if “normal” button 784 is highlighted when edit button790 is selected, then the “freq (end),” “pres (end)” and “time (ramp)”text boxes are grayed out because these parameters are not applicable tothe normal mode of HFCWO therapy operation.

The left side of the screen 800 includes a plurality of numerical keys802 for editing the air pulse generator settings associated with thevarious text boxes on the right side of screen 800. Also included on theleft side of the screen 800 are a scroll down key 804 and back andforward space keys 806, 808. The scroll down key 804 is used to selectthe text box associated with the air pulse generator setting that is tobe edited. Once a particular text box is selected for editing,appropriate presses of keys 802, 806, 808 changes the information in theselected text box. Located in the lower right corner of the screen 800are save and cancel keys 810, 812. Pressing save key 810 causes the airpulse generator settings in the text boxes of screen 800 to be saved inmemory of system 300 for the mode being edited with the changes madethereto, whereas pressing cancel key 812 cancels the changes made to thepatient data in the text boxes of screen 800 such that the previous airpulse generator settings prior to any of the changes being made is savedin memory of system 300 for the respective mode.

FIG. 49 is a screen shot of a data download screen 820 that appears inthe window 428 in response to the data download icon 404 being selected.On the left side of the data download screen 820 is a patient list 822,which lists the patient ID numbers. In some embodiments, a particularpatient is selected by touching the patient ID number on screen 820. Onthe right side of the data download screen 820 are a printer button 824,a PC button 826 and a portable wireless device button 828. Buttons 824,826, 828 are pressed to initiate a data transfer of a patient's data(e.g., date and time of therapy sessions provided to the patient bysystem 300, types of therapy delivered to the patient by system 300, thesettings of the various parameters associated with the therapy sessions,the data associated with any tests or assessments of the patient made bysystem 300 including graphs and tables of such data, and patientinformation stored in system 300) to a printer, a computer, or aportable wireless device, respectively. In response to one of buttons824, 826, 828 being pressed, a data download confirm screen 840 thatappears in window 428 as shown in FIG. 50. On the left side of the datadownload confirm screen 840 is a patient list 842 that corresponds tothe patient list 822 on the screen 820. On the right side of the datadownload confirm screen 840 are confirm and cancel buttons 844, 846. Inthe some embodiments, the data transferred by system 300 is wirelesslytransmitted to an associated device, such as a printer, a PC or a PDA,when confirm button 844 on the data download confirm screen 840 isselected. In some embodiments, the data stored in the system 300 istransmitted over wires to an associated device coupled to system 300.Additionally or alternatively, system 300 may be coupled eitherwirelessly and/or via wires to a network of computer devices, such aslocal area network (LAN), a wide area network (WAN), an Ethernet of ahealthcare facility, or the Internet, and a destination ID may beprogrammed into system 300 or entered by user to specify a device of thenetwork to which the data is to be transmitted from system 300.

FIG. 51 is a screen shot of a help screen 860 that appears in the window428 in response to the help icon 406 being selected. On the left side ofthe help screen 860 is a help topic list 862. In the illustratedembodiment, the help list 862 lists the following topics: vestin-service video, vest user manual, spirometer, nebulizer, clinicalresearch studies, clinical research claims, internal tech support, andmanufacturer tech support. As the names of these various topics suggest,one or more of the memory devices associated with controller 318 ofsystem 300 stores video clips, text and images of manuals, dataregarding clinical studies, and other information that a user of system300 may find useful in connection with learning how to set up andoperate the various therapies of system 300, as well as learning aboutother aspects of system 300. Thus, in response to a user touching aparticular topic on list 862, system 300 responds by showing on theright side of screen 860 an associated video clip, a users manual,information about other listed therapies (e.g., spirometer andnebulizer), view information about clinical studies and claims, andaccess internal and manufacturer technical support contact information.In the lower left corner of the help screen 860 is an exit button 864that when presses, results in the video clip, users manual, or otherinformation no longer being displayed on the right side of screen 860.Having video, manuals, contact information, and other information storedin the memory devices of system 300 results in this information beingavailable to caregivers before, during, or after use of system 300 andis an improvement over prior art therapy devices in which hard copies ofmanuals or other materials and separate video tapes or discs areprovided with the device because such separate pieces of media andinformation may be easily misplaced or lost.

Referring now to FIGS. 24-40 a plurality of garments are shown which aresuitable for use with each of the above-described HFCWO therapy systems100, 200, 300. A wrap 500 having substantially straight upper and loweredges 517, 519 is constructed from inner and outer layers 515 ofmaterial which have substantially the same size and shape as shown inFIG. 24 (only the outer layer 515 can be seen in FIG. 24). The outer andinner layers 515 of material are generally elongated rectangular piecesof material that have generally vertical end edges 523, 525 and that aresealed to each other about the peripheries thereof in any suitablemanner, such as by stitching, sewing, adhering, gluing, bonding, sonicor radio frequency (RF) welding, heat welding, or the like.Alternatively or additionally, some or all of the periphery of the innerand outer layers of material may be coupled together by zippers or otherfasteners, such as hook-and-loop fasteners, buttons, snaps, clasps, andthe like.

In the illustrative embodiment, the majority of the space between layers515 is open and a pair of parallel slits 520 are formed in outer layer515. Slits 520 are sized and configured to receive therein a pair ofhoses such as hoses 118 of system 100, hoses 262 of system 200 or hoses317 of system 300. Slits 520 are oriented generally vertically when wrap500 is worn by a patient, with one of slits 520 being spaced verticallyabove the other of slits 520. Additional details regarding the geometryof slits 520 and the manner in which hoses are inserted through slits520 can be found in U.S. patent application Ser. No. 10/657,728 whichpublished as U.S. Patent Application Publication No. 2005/0054956 A1 onMar. 10, 2005 and which is hereby incorporated by reference herein.

In some embodiments, layers 515 serve as an air bladder that receivesthe oscillating pressurized air from systems 100, 200, 300 and in otherembodiments, a separate air bladder is retained between layers 515, withthe separate air bladder having slits that are in registry with slits520 so that the hoses inserted through slits 520 of the outer layer 515also are inserted through the associated slits of the separate airbladder. In some embodiments, layers 515 may be tacked together, such asby welding, stitching, riveting, buttoning, or the like, at intermittentlocations to prevent excessive ballooning of wrap 500 when inflated.Tacking at some or all of the intermittent locations may be done byinternal tethers, such as stings, straps, bands, and the like, and suchtethers may be of the same length between layers 515 or may be differentlengths at different locations within wrap 500. In embodiments, having aseparate air bladder between the layers 515, the separate air bladdermay be tacked together at intermittent locations. Wrap 500 has suitablefasteners, such as hook-and-loop material (e.g., VELCRO® material) atappropriate locations, such as the end region of one of the ends ofinner layer 515 and the end region of an opposite end of the outer layer515, which couple together to retain wrap 500 on the patient. Othersuitable fasteners, such as buckles, clips, clasps, straps, ties,buttons, and the like, may be used to retain wrap 500 on a patient inother embodiments.

When not used for HFCWO therapy, wrap 500 may remain on a patient ifdesired. Because less surface area of a patient's torso is covered bywrap 500 than is covered by prior art vest-like garments, the patientexperiences less discomfort when continuing to wear wrap 500 after HFCWOtherapy than when wearing the vest-like garments of the prior art. Inaddition, wrap 500 lies substantially flat against the patient's torsowhen not being used for HFCWO thereby reducing the bulkiness of thegarment beneath a patient's shirt or hospital gown, for example. Someprior art vest-like garments have rigid hose connection ports extendingoutwardly from the garment which prevent these sorts of garments frombeing worn beneath a patient's shirt or gown without the shirt or gownhaving a noticeable hump or protrusion. In addition, the simple shape ofwrap 500 allows wrap to be more easily placed on a patient than someprior art vest-like garments having arm holes, shoulder straps, frontand rear vest panels with multiple flaps and straps that need to becoupled together, and the like. For an incapacitated patient, therefore,wrap 500 is much easier for a caregiver to place on a patient than avest-like garment. In addition, due to its relatively small size ascompared to prior art vest-like garments, wrap 500 is less apt tointerfere with various tubes and lines, such as EKG lines, endotrachealtubes, ventilator tubes, and the like, thereby allowing these tubes andlines to remain coupled to the patient whereas use of some of the priorart vest-like garments may require repositioning, removal, ordisconnection of some or all of these tubes and lines from the patient.

Referring now to FIG. 25, a mesh wrap 502 comprises a breathable doublelayer 503 constructed of a mesh or perforated fabric to minimizeperspiration and to keep the patient cooler during HFCWO therapy. In theillustrative example, wrap 502 has substantially straight upper andlower edges 507, 509 with strands 505 of each mesh layer 503 extendingat generally 45° angles relative to edges 507, 509. Strands 505 of eachlayer 503 are woven and are oriented such that the strands which crosseach other do so at generally right angles (e.g., 90°). The outer andinner layers 503 of material are generally elongated rectangular piecesof material that are sealed to each other about the peripheries thereofin any suitable manner, such as use of beading or piping that is eitherwelded (e.g., RF or sonic or heat welding) or use of relatively thinstrips of material that is stitched or sewn in a manner that capturesstrands 505 within the strips. Such strips may be folded over such thatthe fold defines edges 507, 509 with the ends of strands 505 receivedwithin the fold.

Wrap 502 comprises an inflatable bladder that is situated between layers503 and that is inflatable to deliver HFCWO therapy to the patient.Thus, a releasable fastener, such as a zipper or hook-and-loop fastenerstrips or buttons or the like may be provided along a portion of one ofedges 507, 509 to allow for insertion of and removal of the inflatablebladder between layers 503. The inflatable bladder is sized to cover thefront and, if desired, the sides of the patient. One or more suitableports are provided for connection of hoses to the inflatable bladder.The one or more ports may protrude from the bladder between associatedones of the strands 505 which are diverted around the protruding port orports. In other embodiments, flanges or other connection structure maybe provided around the end of the one or ports and certain one of thestrands 505 may terminate at and be connected to such connectionstructure of the one or more ports. For example, the connectionstructure may be a plastics material that is molded around the ends ofthe associated strands 505. In such embodiments, the inflatable bladdermay not be removable from between layers 503 although, they could be ifsuitable detachable couplers are provided between the one or morebladder inlets and the one or more ports just described. Suitablefasteners, such as those listed above in connection with wrap 500, areprovided at the end regions of wrap 502 for connection to each other toretain wrap 502 on the patient.

In alternative embodiments, a single mesh layer 503 is provided in theback region and possibly the side regions of the wrap 502 and fabriclayers similar to layers 515 of wrap 500 are provided in the frontregion and possibly the side regions of wrap 502. In such embodiments,the mesh layer 503 and the fabric layers may be coupled together along aseam located near one of the side regions of the wrap and releasablefasteners that couple the mesh layer to the fabric layers near the otherof the side regions of the wrap. Thus, in such embodiments, the fronthalf (including some or all of the side regions of the wrap) isconstructed like wrap 500 and the back half (including some or all ofthe side regions of the wrap) are constructed like wrap 502, but withonly a single mesh layer 503.

Referring now to FIG. 26, a low air loss wrap 504 comprises apatient-facing inner layer 521 of material having a plurality ofperforations 522 through which pressurized air is expelled to enhancethe evaporation of any moisture, such as perspiration, thereby topromote cooling of the patient during HFCWO therapy. The outer layer ofwrap 504 is substantially the same as the outer layer 515 of wrap 500.Thus, the layers of wrap 504 are substantially rectangular in shapehaving straight upper and lower edges 517, 519 as was the case with wrap500. Wrap 504 has substantially straight left and right vertical edges523, 525 as shown in FIG. 26.

The inner and outer layers of wrap 504 are coupled together about theirperipheries in any of the manners described above in connection withwrap 500. In addition, any of the fasteners described above inconnection with retention of wrap 500 on the patient may be provided toretain wrap 504 on the patient. Wrap 504 may have slits similar to slits520 of wrap 500 or may have one or more ports that protrude from theouter layer for connection of hoses thereto. The layers or wrap 504 mayalso be tacked together at intermittent locations, such as midwaybetween various ones of perforations 522, in any of the mannersdescribed above in connection with wrap 500. In some embodiments, thespacing between perforations may vary such that the number ofperforations in any given area (e.g., number of perforations per squareinch or square foot or square centimeter) is different. For example,there may be a greater density of perforations adjacent to the upper andlower edges 517, 519 of wrap 504 than in the middle region of wrap 504between edges 517, 519, or vice versa. In some embodiments, a greaterdensity of perforations may be provided in the back region and/or sideregions of wrap 504 than in the front region, or vice versa.

Referring now to FIG. 27, a wrap 506 has flat tubing 526 integratedtherewith. Wrap 506 is constructed similarly to wrap 500 discussedabove. Therefore, like reference numerals are used to denote portions ofwrap 506 that are substantially the same as like portions of wrap 500.Wrap 506 has a pair of parallel slits 524 through which respective flattubes 526 are routed. In some embodiments, tubes 526 connect to anassociated inflatable bladder that is situated between layers 515 ofwrap 506. In other embodiments in which the layers 515 themselves serveas an inflatable bladder, the ends of tubes 526 in the space betweenlayers 515 are coupled in a suitable manner to the outer layer 515 inthe region surrounding slits 524. Such coupling of tubes 526 to layer515 may be accomplished by adhering, bonding, gluing, welding (RF orsonic or heat), or by sewing or stitching, for example.

It is contemplated by this disclosure that, in some embodiments, theends of tubes 526 have outwardly extending flanges that are coupled tothe interior surface of out layer 515 adjacent to slits 524. In otherembodiments, such flanges are coupled to the exterior surface of outerlayer 515. In still other embodiments, layer 515 may comprises multiplesheets or layers of material and the flanges at the ends of tubes 526may be situated between two sheets of such a multi-sheet layer 515. Itis also within the scope of this disclosure for tubes 526 to be coupledto wrap 506 by a separate coupler, such as ring of material to whichtubes 526 couple and that couples to outer layer 515. Based on theforegoing, it will be appreciated that tubes 526 remain permanentlyconnected to the wrap 506 which reduces the potential for losing ormisplacing the tubes 526. In addition, the flat tubes 526 occupy lessstorage space than other tubes disclosed herein which do not collapseinto a flat configuration when not in use. Tubes 526 and wrap 506 may berolled up or folded together for storage.

In use, tubes 526 inflate at least to some extent due to the associatedair pulses being communicated therethrough by the associated system 100,200, 300 with which wrap 506 is used. In some embodiments, tubes 526 aremade of a material having suitable thickness and rigidity, but yet arestill sufficiently flexible, to permit a caregiver to squeeze or deformthe respective distal end regions 527 of tubes 526 into a substantiallycylindrical shape for insertion into the ports 112, 260, 334 of theassociated system 100, 200, 300 with a slight press fit between endregions 527 and the material defining the cylindrically shaped ports112, 260, 334. In other embodiments, tubes 526 are made of a more flimsymaterial and adapters, such as fairly rigid and hollow cylinders, areprovided for insertion into end regions 527 of tubes 526 and forinsertion into ports 112, 260, 334 of the respective system 100, 200,300. Each of such adapters, therefore, may extend partially into theassociated tube 526 and partially into the associated port 112, 260,334. In addition, such adapters may have barbs or annular ribstherearound to enhance the retention of tubes 526 on the adapters.

Referring now to FIG. 28, a sheet clamped garment 508 wraps around thefront and at least a portion of the sides of a patient but does notextend over the patients back. Thus, the patient does not need to bemoved to place garment 508 on the patient for use. Garment 508 includesinner and outer layers 509 of material that are generally rectangular inshape and that are fastened together about the peripheries thereof inany of the manners described above in connection with wrap 500. Thus,garment 509 has generally straight upper and lower edges 531, 533 andgenerally straight side edges 535, only one of which can be seen in FIG.28. Ports 532 protrude from the outer layer 509 and are configured forconnection to tubes or hoses that are, in turn, coupled to the ports112, 260, 334 of the associated system 100, 200, 300. In theillustrative example, ports 532 are positioned side-by-side such thatone of ports 532 is spaced horizontally from the other of ports 532. Inalternative embodiments, ports 532 are omitted and garment 508 has slitssimilar to slits 520 described above in connection with wrap 500.

The opposite ends of the garment 508 have respective pairs of tethers orstraps 529 extending therefrom as shown in FIG. 28. Straps 529 may becoupled to layers 509 in any suitable manner such as stitching orriveting or RF welding, for example. In such embodiments, the endregions of straps 529 proximal to layers 509 may be situated between theinner and outer layers 509 and fastened thereto during the samefastening procedure, such as stitching or welding, that layers 509 arefastened to each other. In some embodiments, buckles or other releasablefasteners may couple straps 529 to layers 509 thereby providingadjustably to the amount that straps 529 extend away from layers 509 sothat patients of different sizes may be accommodated.

A clamp 530 is coupled to each of straps 529 and each clamp 530 isconfigured to grip a sheet 528 which underlies the patient. The straps529 and/or clamps 530 are adjustable so that garment 508 may be heldtightly against the patient. In some embodiments, therefore, free endsof straps 529 extend beyond clamps 530 and may be pulled by a caregiverto tighten garment 508 in place relative to the patient. In otherembodiments, straps 529 are elastic and are stretched before clamps 530are coupled to the sheet 528 underlying the patient such that theelasticity of the straps 529 stretched in this manner exerts a force onthe layers 509 of garment 508 which retains garment 508 in place on thepatient. The sides of sheet 528 may be bunched up prior to couplingclamps 530 to the bunched up portion of the sheet 528. In addition,clamps 530 each have members, such as jaws, clam shell members, cams, orthe like, that are manipulatable between a gripping position to firmlygrip the sheet 528 between such members of the associated clamp 530 anda releasing positions to allow the sheet 528 to be inserted into orremoved from the associated clamp 530.

Garments 550, 552, 554 shown in FIGS. 29-31, respectively, each havemultiple air chambers that permit customization of HFCWO therapy forindividual patients. Illustrative garments 550, 552, 554 are vests andtherefore, are referred to in the following description as vests 550,552, 554, respectively. However, the features of vests 550, 552, 554 maybe employed in other garments such as any of wraps discussed above orapron-like garments discussed below. Vest 550 shown in FIG. 29 hasmultiple bladders 580′, 580″, 580′″ defining air chambers that aregrouped into left and right pairs with the chambers of each pair beingpositioned generally over the upper, middle, and lower lobes of thepatients lungs, respectively.

In the illustrative example of vest 550, upper bladders 580′ receivepressurized air from the associated system 100, 200, 300 to which vest550 is coupled. Although not illustrated, a port or slit (similar to anyof those discussed above in connection with other garment embodiments)for coupling bladders 580′ to the associated system 100, 200, 300 isprovided on each of bladders 580′ or elsewhere on vest 550. If providedelsewhere on vest 550, conduits internal to vest 550 are routed tobladders 580′ and also to bladders 580″, 580′″ from the respective portsor slits. Vest 550 has a zipper 585 or other suitable releasablefastener, such as hook-and-loop fasteners, straps, buckles, buttons, orthe like, for closing the left and right front flaps of vest 550 infront of the patient. In the illustrative embodiment, zipper 585 ispositioned along a midline of the front of the patient.

Vest 550 has a plurality of flow regulators 582′, 582″ that can beselectively activated or deactivated to control the provision ofoscillatory pressure to associated bladders 580″, 580′″. Illustratively,flow regulators 582′, 582″ each have associated knobs 583 that areaccessible on the exterior of vest 550 and that are coupled torespective valves (not shown) that are situated in the respectivepneumatic flow paths from chambers 580″, 580′″ to the air pulsegenerator (not shown) of the respective system 100, 200, 300 to whichvest 550 is coupled. Knobs 583 are turned to vary an orifice of thecorresponding valve thereby to adjust the amplitude and/or the baselinepressure of the oscillatory pressure that inflates the chambers ofbladders 580″, 580′″. Regulators 582′, 582″ may be adjusted, therefore,between fully opened and fully closed positions and set at any number,including an infinite number in some embodiments, of intermediatepositions between the fully opened and fully closed positions. In theillustrative embodiment, each bladder 580′, 580″, 580′″ has a cutout 587to accommodate a portion of an associated one of knobs 583.

In some embodiments, knobs 583 and/or the associated valves havesuitable locking mechanisms or detent mechanisms that prevent or resistknobs 583 and/or valves from inadvertently turning out of the chosenposition during HFCWO therapy. For example, regulators 582′, 582″ mayinclude mechanisms that bias knobs 583 outwardly away from vest 550 (orinwardly toward vest 550) such that knobs 583 need to be pushed inwardlytowards vest 550 (or pulled outwardly away from vest 550) to unlock theknobs 583 for turning. In other embodiments, knobs 583 may each have oneor more buttons that need to be squeezed or pressed before knobs 583 areunlocked for turning. If detent mechanisms are provided in regulators582′, 582″, such detent mechanisms are fashioned such that a user isable to rotatably index knobs 583 from one setting to another byapplication of a sufficient amount of torque to knobs 583, but thedetent mechanisms have sufficient holding or resistive force that knobs583 don't inadvertently index from one setting to another in response tothe vibratory or shaking forces to which vest 550 is subjected duringHFCWO therapy.

In the illustrative example, the chambers of bladders 580′ are inflatedwith oscillating pressure as provided directly from the associated airpulse generator whereas, regulators 582′, 582″ are adjustable so thatthe chambers of bladders 580″, 580′″ may be inflated with a lesserbaseline pressure and/or a lesser amplitude as compared to the chambersof bladders 580′, if desired. In other embodiments, additional flowregulators are provided to enable adjustment of the oscillatory pressurereaching bladders 580′ as well. In further embodiments, the oscillatingpressure from the associated air pulse generator is communicateddirectly to the chambers of bladders 580″ and regulators 582′ areassociated with bladders 580′ to permit adjustment of the baselinepressure and/or amplitude of the oscillatory pressure reaching thechambers of bladders 580′.

In some embodiments of vest 550 contemplated herein, bladders 580′,580″, 580′″ are connected in series such that regulators 582′ areprovided in the flow path between bladders 580′ and bladders 580″ andsuch that regulators 582″ are provided in the flow path between bladders580″ and bladders 580′″. Assuming that bladders 580′ are coupleddirectly to the source of oscillating pressure, the oscillatory pressurepulses reaching bladders 580″ are received from associated bladders 580′through regulators 582′ and the oscillatory pressure pulses reachingbladders 580′″ are received from associated bladders 580″ throughregulators 582″. In other embodiments, bladders 580″, 580′″ may becoupled to respective bladders 580′ in parallel such that regulators582′ are provided in the flow path between bladders 580′ and bladders580″ and such that regulators 582″ are provided in the flow path betweenbladders 580′ and bladders 580′″. In still other embodiments, ifbladders 580″ are coupled directly to the source of oscillatingpressure, then bladders 580′ and 580′″ may be connected to bladders 580″in parallel such that the oscillatory pressure pulses reaching bladders580′ are received from associated bladders 580″ through regulators 582′and such that the oscillatory pressure pulses reaching bladders 580′″are received from associated bladders 580″ through regulators 582″. Itis also within the scope of this disclosure for bladders 580′″ toreceive pressure pulses directly from the source of oscillatory pressureand then communicate the pressure pulses upwardly to bladders 580′, 580″through regulators 582′, 582″ either along serial or parallel flowpaths.

The vest 552 shown in FIG. 30 has an upper pair of bladders 590′defining upper inflatable chambers and a lower pair of bladders 590″defining lower inflatable chambers. In some embodiments, bladders 590′are coupled to an air pulse generator, such as those of systems 100,200, 300, using associated hoses 118, 262, 317, and in otherembodiments, bladders 590″ are coupled to an air pulse generator. Thus,vest 552 has suitable slits or ports (not shown, but similar to any ofthose described above) for connection of hoses which are routed to asource of oscillating pressure. A hose 592 extends between each upperbladder 590′ and the associated bladder 590″ therebelow. The ends ofeach hose 592 are coupled to a respective fitting 593, each of whichprotrudes from a respective bladder 590′, 590″. Thus, each bladder 590′is in pneumatic communication with an associated one of bladders 590″through corresponding hoses 592.

A flow regulator 594 is coupled to each tube 592 and is movable to openand close the flow passage through the tube 592 thereby to open andclose pneumatic communication between bladders 590′ and bladders 590″.In the illustrative example, flow regulators 594 comprises tube clampswhich are mounted to tubes 592 and which have fully opened and fullyclosed positions. Thus, illustrative hoses 592 are made of a material,such as rubber or silicone, which permits hoses 592 to collapse underthe force of the tube clamps to close off the internal passage throughhoses 592. In other embodiments, flow regulators 594 may haveintermediate positions between the fully opened and fully closedpositions, such as a tube clamps which only partially squeezes orcollapses the associated tube 592. In some embodiments, vest 552 mayhave additional bladders, such as a third pair of bladders similar tovest 550, with additional hoses 592 and flow regulators 594 beingprovided between one or the other of bladders 590′, 590″ and anassociated one of the additional bladders. In alternative embodiments,individual the chambers of bladders 590′, 590″ may be closed off byusing press-and-seal material or a zip lock arrangement, similar toSaran™ press-and-seal wrap, either within a flow conduit betweenbladders 590′, 590″ or at the boundary where such flow conduits meetsthe chambers of respective bladders 590′, 590″.

Referring now to FIG. 31, a vest 554 has an upper pair of bladders 600′defining an uppers pair of inflatable chambers and a lower pair ofbladders 600″ defining a lower pair of inflatable chambers. Bladders600′, 600″ are coupled by associated hoses 602 to an air pulse generator610 which comprises a first air pulse module 612 and a second air pulsemodule 614. A fitting 603 couples one of the ends of each of hoses 602to an associated bladder 600′, 600″. In the illustrative example, upperbladders 600′ are coupled pneumatically to the first air pulse module612 as indicated by numerals 1 and 2 on bladders 600′ and numerals 1 and2 adjacent arrows leading from module 612. Similarly, lower bladders600″ are coupled pneumatically to the second air pulse module 614 asindicated by numerals 3 and 4 on bladders 600″ and numbers 3 and 4adjacent arrows leading from module 614. Module 612 is operableindependently of module 614 such that each module 612, 614 may operateaccording to different operating parameters, such as baseline pressure,frequency, and duration of operation. Thus, the intensity and frequencyof oscillatory forces imparted on the patient by bladders 600′ may bedifferent than the intensity and frequency of oscillatory forcesimparted on the patient by bladders 600″.

As shown diagrammatically in FIG. 31, a common controller 616 commandsthe operation of modules 612, 614. In addition, modules 612, 614 andcontroller 616 may be housed in a common housing 618. Separate userinputs, such as separate fields of a touch screen display, may beprovided for entry of the different operating parameters for modules612, 614. If desired, however, modules 612, 614 may be programmed tooperate in accordance with identical operating parameters. In otherembodiments, separate controllers may be provided for each of modules612, 614. Modules 612, 614 may be substantially similar to thedual-diaphragm air pulse modules described in U.S. Patent ApplicationSerial No. 2004/0097842 which is already incorporated by referenceherein. Of course, it is intended that air pulse modules of all typesmay be included in air pulse generator 610, including single diaphragmair pulse modules, piston type air pulse modules, valve type air pulsemodules, and the like.

In the illustrative example, generator 610 is configured to providepressure pulses to each of bladders 600′ at a substantially identicalbaseline pressure and/or amplitude and to provide pressure pulses toeach of bladders 600″ at a substantially identical baseline pressureand/or amplitude. In alternative embodiments, a flow regulator, such asvalve may be associated with any one or more of hoses 602 to permitadjustment of the baseline pressure and/or amplitude of the oscillatingpressure reaching any particular one of the associated bladders 600′,600″. Thus, in such embodiments, the pressure characteristics of theoscillatory pressure reaching each individual bladder 600′, 600″ may beunique and different than that of each of the other bladders 600′, 600″.Such flow regulators may be coupled to and/or housed within housing 618and may be electronically controlled by controller 616. In still otherembodiments, more than two air pulse modules may be provided ingenerator 610. For example, if four modules are provided, then eachmodule may be operated at its own unique frequency such that thefrequency of oscillating pressure reaching each of bladders 600′, 600″is unique and different than that of each of the other bladders 600′,600″ It is contemplated by this disclosure, therefore, that specificbladders 600′, 600″ of vest 554 can be inflated according to differentpressure and frequency settings.

Vests 556, 558, 560, shown in FIGS. 32-34, are designed to promotepatient ventilation and cooling. For example, an interior layer of thevest 556 shown in FIG. 32 is made of a wicking fabric to absorb moistureaway from a patent's skin for evaporation into the inflatable chamber ofvest 556 and then, for ultimate passage to the ambient surroundingsthrough the exterior of vest 556 as indicated by arrows 557. Vest 556has perforations or other holes or passageways through which pressurizedair within the inflatable chamber of vest 556 escapes to the ambientsurroundings. Such passageways may be created, for example, due to astitching operation that fastens inner and outer layers of vest materialtogether to form the inflatable chamber of vest 556. The thread whichpasses through the punctures formed in the layers of vest 556 by theassociated needle of the stitching operation does not completely fillthe needle punctures such that the needle punctures provide thepassageways to the ambient surroundings. Additionally or alternatively,other discrete holes may be formed in the outer layer through whichpressurized air is expelled from vest 556 to the ambient surrounding.The convective movement or flow of pressurized air through vest 556enhances the evaporation of the moisture wicked through the interiorlayer of vest 556.

As shown in FIG. 33, an inner layer 660 of a low air loss vest 558 has anumber of perforations 672 through which pressurized air is expelled toimprove evaporation of moisture, such as perspiration, during HFCWOtherapy. The inner and outer layers of vest 558 may also be tackedtogether at intermittent locations, such as midway between various onesof perforations 522, in any of the manners described above in connectionwith wrap 500, in order to prevent ballooning of vest 558 duringinflation. In some embodiments, the spacing between perforations 672 mayvary such that the number of perforations in any given area (e.g.,number of perforations per square inch or square foot or squarecentimeter) is different. For example, there may be a greater density ofperforations adjacent to neck, arm, and waist holes of vest 558 than inthe middle region of vest 558, or vice versa. In some embodiments, agreater density of perforations may be provided in the back regionand/or side regions of vest 558 than in the front region, or vice versa.

Referring now to FIG. 34, a vest 560 has one or more conduits orchannels 620 through which cooling fluid is circulated to promotepatient cooling. The cooling fluid may be either a cooled liquid or acooled gas. In the illustrated embodiment, the cooling fluid is suppliedby a cooling system 622, such as the Medi-Therm Hyper/Hypothermia Systemmarketed by Gaymar Industries Inc. of Orchard Park, N.Y. Theillustrative vest 560 shown in FIG. 34 has multiple bladders 624defining chambers that receive oscillatory pressure for HFCWO therapy.In other embodiments, vest 560 has only a single inflatable chamberdefined by inner and outer layers of vest material or defined by asingle bladder situated between the inner and outer layers of vestmaterial, although multiple chambers are not necessary for patientcooling. Vest 560 shown in FIG. 34 is similar to vest 552 shown in FIG.30, in that vest 560 also has fittings 593 and hoses 592 forpneumatically coupling upper and lower bladders 624 to each other.Illustrative vest 560 does not have any flow regulators coupled to hoses592 but, of course, flow regulators may be coupled to hoses 592 in otherembodiments of vest 560 if desired.

Conduits 620 are routed through vest 560 along generally serpentinepatterns with generally straight segments of the channels being orientedvertically (assuming the patient is standing as shown in FIG. 34) andwith loops or curves of the conduits 620 being situated near the bottomand top of the vest 560. In other embodiments, conduits 620 may berouted through vest 560 along some other pattern, including aside-to-side serpentine pattern rather than the illustrative up-and-downserpentine pattern. Conduits 620 may be coupled to the exterior of vest560 as shown in FIG. 34, or may be coupled to the interior of vest 560or embedded between layers of vest material in other embodiments.

Conduits 620 may be separated into a left and a right conduit 620 withthe right conduit 620 extending over the front and back of vest 560 onthe right side thereof and the left conduit 620 extending over the frontand back of vest 560 on the left side thereof. Each of conduits 620 mayhave a port which is configured to couple to ends of hoses 621 whichextend from system 622. In the illustrative example of FIG. 34, twohoses 621 are shown with one hose 621 coupling to the right conduit 620and the other hose coupling to the left conduit 620. Each conduit 620may comprise dual lumens or passageways therethrough which interconnectadjacent terminal ends of respective conduits 620. Thus, cooling fluidfrom system 622 travels down one of the lumens of each conduit 620toward the terminal end 623 thereof and then returns back to system 622through the other of the lumens of conduit 620. In such embodiments,hoses 621 also have dual lumens with one lumen being a fluid deliverylumen and the other being a fluid return lumen.

In other embodiments, the left and right conduits 620 may have only asingle lumen or passage therethrough with a connection port beingprovided at each end of such single-lumen conduits 620 such that one ofthe hose connection ports is an entry port that receives fluid fromsystem 622 and the other of the hose connection ports is an exit portthrough which fluid is returned to system 622. In still otherembodiments, vest 560 has a only a single conduit 620. For example, if ahose connection port for connection of hoses 621 is provided at eachterminal end 623, then a fluid delivery hose 621 could be attached toone of the ports at the associated end 623 of conduit 620 and a fluidreturn hose 621 could be attached to the other of the ports at the otherend 623 of conduit 620. In such embodiments, the roles of the fluiddelivery and fluid exit ports may be reversed periodically, such thatthe direction of flow of cooling fluid through hoses 621 and conduit 620is reversed periodically, so as to compensate for the fact that thecooling fluid heats up while traveling through conduit 620 and reversingwhich end 623 of conduit 620 initially receives the cooling fluid fromsystem 622 results in alternating, from time to time, which side of thepatient is exposed to the cooler fluid. Such a reversal of the directionof travel of the cooling fluid through conduit 620 is controlled byvalves and other components internal to system 622 in these embodiments.

Backless apron-like configurations of garments 562, 564, 566 are shownin FIGS. 35-39 and are designed to enhance the ease with which thesegarments are placed on a patient. Garments 562, 564, 566 are sometimesreferred to herein as aprons 562, 564, 566. Garments 562, 564, 566 canbe secured to the patient by a single caregiver while the patientremains supine and relatively undisturbed, although some movement of thepatient may be required. If desired, garments 562, 564, 566 may remainon a patient even when the patient is not undergoing HFCWO therapy. Inthe illustrative examples, no ports or slits for connection to hoses ofsystems 100, 200, 300 are shown, but it is to be understood that each ofaprons 562, 564, 566 has such ports or slits through which oscillatorypressure is communicated to one or more inflatable bladders of each ofaprons 562, 564, 566. Such one or more bladders of each of aprons 562,564, 566 may be defined between layers of material of the respectiveapron or may be a separate bladder that is retained between the layersof material of the respective apron. Bladders that attach to a singleapron layer (or a single wrap layer or a single vest layer), such aswith snaps or the like, are also contemplated by this disclosure.

Referring to FIG. 35, apron 562 has a vest-like front appearance but ismissing a back and a portion of each of the sides. Thus, unlike wrap508, apron 562 has a portion that extends up and around the patient'sneck and an inflatable bladder of apron 562 covers more of the front ofthe patient's torso than the inflatable bladder of wrap 508. On theopposite sides of apron 562 in the region of apron 562 between thepatient's armpits and waist, a pair of straps or tethers 631 extendtherefrom and a clamp 632 is coupled to each of straps 631. Thediscussion above of straps 529 of wrap 508, including the manner ofattachment to the associated garment and the manner of attachment to theassociated clamp, is equally applicable to straps 631 of apron 562. Inaddition, the discussion above clamps 530 of wrap 508 is equallyapplicable to clamps 632 of apron 562. Thus, straps 631 may be coupledto the material layers of apron 562 in any suitable manner such asstitching or riveting or RF welding, for example. In such embodiments,the proximal end regions of straps 631 may be situated between the innerand outer layers of apron 562 and fastened thereto during the samefastening procedure, such as stitching or welding, that the layers ofapron 562 are fastened to each other. In some embodiments, buckles orother releasable fasteners may couple straps 631 to the bladdercontaining portion of apron 562 thereby providing adjustably to theamount that straps 631 extend away from the sides of apron 562 so thatpatients of different sizes may be accommodated.

Clamp 632 is coupled to each of straps 631 and each clamp 632 isconfigured to grip a sheet 630 which underlies the patient. The straps631 and/or clamps 632 are adjustable so that garment 562 may be heldtightly against the patient. In some embodiments, therefore, free endsof straps 631 extend beyond clamps 632 and may be pulled by a caregiverto tighten garment 562 in place relative to the patient. In otherembodiments, straps 631 are elastic and are stretched before clamps 632are coupled to the sheet 630 underlying the patient such that theelasticity of the straps 631 stretched in this manner exerts a force onthe bladder-containing portion garment 562 which retains garment 562 inplace on the patient. The sides of sheet 630 may be bunched up prior tocoupling clamps 632 to the bunched up portion of the sheet 630. Inaddition, clamps 632 each have members, such as jaws, clam shellmembers, cams, or the like, that are manipulatable between a grippingposition to firmly grip the sheet 630 between such members of theassociated clamp 632 and a releasing positions to allow the sheet 630 tobe inserted into or removed from the associated clamp 632.

Referring now to FIGS. 36 and 37, apron 564 has a front panel 647including a generally straight bottom edge 649, a pair of shoulder flapsor coverings 648 that extend up and over the top of the patient'sshoulders, and a concave upper edge 645 that dips downwardly relative tothe upper most portion of shoulder flaps 648 to accommodate a patient'sneck area. A pair of shoulder straps 640 each have an upper end coupledto a respective one of the shoulder flaps 648 and each have a lower endcoupled to respective side region of front panel 647 below, and inspaced relation from, the associated upper end. Thus, straps 640cooperate with front panel 647 to form loops through which a patient'sarms are passed to secure garment 564 on the patient.

In some embodiments, one of the ends, either the upper end or lower end,of each strap 640 are permanently fastened to front panel 647, such asby stitching, bonding, riveting, gluing, adhering, welding (sonic, RF,or heat), or the like, and the other end of each strap 640 is releasablyfastened to front panel 647 by a suitable coupling mechanism such as,for example, buckles, clips, clasps, hook-and-loop fasteners, buttons,snaps, and the like. In other embodiments, both ends of straps 640 arepermanently fastened to panel 647 or both ends of straps 640 arereleasably fastened to front panel 646. Additionally or alternatively,the length of straps 640 may be adjusted via suitable adjusters, such asbuckles, eyelets, or the like. For example, straps 640 may bepermanently coupled to the sides of panel 647 at their lower ends andloop through an eyelet coupled to shoulder flaps 648 and then doubledback on themselves so that hook-and-loop patches on the straps 640 canintermesh to retain garment 564 on a patient.

When the one or more bladders of garment 564 are inflatably pulsedduring HFCWO therapy of the associated patient, it will be appreciatedthat the shoulder straps 640 in cooperation with shoulder flaps 648prevent the upper region of front panel 647 from expanding, in anyappreciable sense, away from the patient, thereby enhancing andconcentrating the oscillatory forces imparted on the patient in theupper chest area as compared to the lower chest area in which frontpanel 647 is able to move away from the patient to a greater extent. Inother embodiments, a back or waist strap may extend around the patient'swaist from one side of the bottom region of front panel 647 to the otherto prevent or reduce the movement of the bottom region of front panel647 away from the patient during HFCWO therapy. Such a waist strap maybe coupled to front panel 647 in any of the manners described above inconnection with straps 640 and therefore, may have any of theabove-described permanent fasteners, releasable fasteners, and lengthadjusters. In some embodiments, the shoulder straps 640 and/or waiststraps used for securing garment 564 on a patient may be provided withgraduated markings to aid in repeated fittings of apron 564 on the samepatient.

Referring now to FIGS. 38 and 39, apron 566 comprises a front panel 567with a generally straight bottom edge 565, a neck strap 650 extendingfrom one side of an upper region of panel 567 to another to form a loopthrough which the patient's head is passed, and a pair of back straps652 which couple together to secure apron 566 on the patient.Furthermore, front panel 567 has side flaps 569 that extend around thesides of the torso of the patient beneath the patient's armpits. Bothends of strap 650 are permanently fastened to panel 567 in any of themanners described above in connection with straps 640 of garment 564.Similarly, one end of each back strap 652 is permanently fastened to arespective one of side flaps 569. Suitable couplers 653 are mounted toeach strap 653 and are configured to mate together. Such couplers 653may comprise, for example, buckles having interlocking members, such asflexible fingers received in pockets, or the like. In some embodiments,one or both straps are routed through couplers 653 such that a free endof one or both straps 652 may be pulled to tighten straps 652 and panel567 on the patient. In some embodiments of apron 566, the back straps652 may be provided with graduated markings to aid in repeated fittingsof garment 566 on the same patient.

Referring not to FIG. 40, a vest 568 is manufactured from clinicalcamouflage fabric which hides stains. The clinical camouflage fabric isimpregnated with activated charcoal and/or antimicrobial agent toinhibit odors and/or bacterial growth. The interior and exterior layersof vest 568 may comprise such clinical camouflage fabric. Additionallayers of material of other types may be laminated to each of theclinical camouflage layers included in vest 568, if desired. It shouldbe understood that any of the garment disclosed herein (i.e., the wraps500, 502, 504, 506, 508, vests 550, 552, 554, 556, 558, 560, 568, andaprons 562, 564, 566 discussed above) may have one or more layerscomprising a clinical camouflage material, if desired.

All permutations and variations of features described above in eachgarment embodiment are intended to be applicable to each of the othergarment embodiments, such that features may be mixed and matched tocreate additional embodiments in accordance with this disclosure. Forexample, aprons 562, 564, 566 may include multiple bladders withassociated flow regulators of the type included in vests 550, 552, 554;wraps 500, 502, 504, 506, 508 may have an interior layer made fromwicking material of the type included in vest 556; wraps 500, 502, 504,506, 508 and aprons 562, 564, 566 may have cooling conduits for receiptof a cooling fluid from a cooling system similar to the manner in whichconduits 620 of vest 560 receive cooling fluid from system 622; vests550, 552, 554, 556, 558, 560, 568 and aprons 562, 564, 566 may have flattubes integrated therewith similar to the manner in which flat tubes 526are integrated with wrap 506. These are but a few examples of thepossibilities for mixing and matching garment features within the scopeof this disclosure. In addition, one or more of the layers of materialof each of the garment described herein may comprise any suitablematerials such as polyethylene, polystyrene, polycarbonate, or even apolyester material, such as Hydra-tuff 600 denier polyester with a 7ounce per square yard PVC laminate.

Referring now to FIGS. 52 and 53, a HFCWO therapy system 900 includes anair pulse generator 902 coupled to a shelf 904 of a wheeled pedestal906. Fasteners, such as screws or bolts (not shown) are used to coupleair pulse generator 902 to shelf 904 in some embodiments. Other types offasteners, such as tabs, fingers, brackets, clips, and the like may beused to couple air pulse generator 902 to shelf 904 in otherembodiments, if desired. Shelf 904 has a larger footprint than the airpulse generator 902 of system 900 such that the shelf 904 has portionsextending beyond the front, back, and sides of the air pulse generator902 as shown best in FIG. 53. In the illustrative embodiment, air pulsegenerator 902 is a Model 104 system which is marketed by AdvancedRespiratory, Inc. of St. Paul, Minn. and which is disclosed in U.S.patent application Ser. No. 10/295,782 which published as US PatentApplication Publication No. US 2004/0097842 and which is alreadyincorporated by reference herein. In other embodiments, air pulsegenerator 902 has additional functions such as those discussed above inconnection with FIGS. 5-23 and 41-51. Thus, a spirometry mouthpieceand/or nebulizer mouthpiece, such as any of those described herein, maybe coupled to air pulse generator 902.

One side of shelf 904 has a notch 908 opening into an aperture 910 thatextends between the top and bottom surfaces of shelf 904 as shown inFIG. 53. Notch 908 permits hoses or electrical lines to passtherethrough such that an item associated with the hose or electricalline can be stored within or above aperture 910 on shelf 904. The itemmay be, for example, a controller (e.g., hand pendant or foot switch)for controlling air pulse generator 902 or a mouthpiece. In theillustrative example, aperture 910 is circular, but apertures 910 ofother shapes are within the scope of this disclosure. A hand aperture912 is provided in a front region of shelf 904 such that a front section914 of shelf 904 serves has a grip handle. Aperture is oval-shaped inthe illustrative example and is long enough to accommodate a portion ofa caregiver's hand therein so as to enable the caregiver to grip section914 when maneuvering system 900 along a floor. In other embodiments,aperture 912 may have shapes other than oval.

A push handle 916 is coupled to the bottom surface of shelf 904 andextends rearwardly therefrom as shown in FIGS. 52 and 53. Push handle916 is a tubular bar formed as a loop, with the loop extending laterallyby about the same among as the lateral distance between the sides ofshelf 904. A caregiver may grasp handle 916 to maneuver system 900 alonga floor, such as when pushing the system 900 from behind. A hook 918 isalso coupled to the bottom of shelf 904 and extends rearwardly therefromas shown in FIG. 53. Items, such as any of the garments described above,may be hung on hook 918 for storage or while system 900 is beingtransported from one place to another in a healthcare facility.

Pedestal 906 comprises a vertically oriented telescopic column 920having an upper segment 922 and a lower segment 924 as shown in FIG. 52.Upper segment 922 may be raised and lowered relative to lower segment924 to adjust the elevation at which shelf 904 supports air pulsegenerator 902. Pedestal 906 also has a pair of front legs 926 and a pairof rear legs 928, with each of these legs 926, 928 being coupled tolower segment 924 of column 920. Casters 930 are coupled to distal endsof legs 926, 928 for swiveling movement about substantially verticalaxes. Wheels of casters are rotatable about substantially horizontalaxes. In the illustrative example, legs 926 are curved such that theyinitially protrude from lower segment 924 in a laterally extendingdirection and then curve forwardly such that the distal end regions oflegs 926 extend in a forward direction. In addition, the width of eachof legs 926 is relative thin and uniform along the curvature thereof,but legs 926 are tapered in vertical height from the proximal ends tothe distal ends thereof.

Rear legs 928 are generally straight but angle laterally outwardly andrearwardly from segment 924 to which they are coupled. In addition, rearlegs 928 are tapered in vertical height from the proximal ends to thedistal ends thereof. Legs 928 are shorter in length than legs 926. Thiscompensates for the fact that, in the illustrative example, column 920is coupled to shelf 904 closer to the rear edge of shelf 904 than to thefront edge. As can be seen in the top plan view of FIG. 52, legs 926,928 are sized and configured so that the two front casters are situatedsubstantially vertically beneath the front corner regions of shelf 904and the two rear casters are situated substantially vertically beneaththe more sharply curved lateral side portions of handle 916.

A chart holder 932, in the form of a wire basket in the illustrativeexample, is coupled to a front of upper segment 922 of telescopic column920 as shown in FIG. 52. A pair of hose clips 934 are also provide onpedestal 906 and are coupled to the sides of upper segment 922 oftelescopic column 920 in the illustrative embodiment. Hoses, such as anyof those described above, for coupling ports 936 of air pulse generator902 to an associated garment, may be releasably gripped by hose clips934 during storage or transport. Thus, chart holder 932 and hose clips934, as well as any items carried thereby, raise and lower along withsegment 922 as segment 922 is raised and lowered relative to segment924.

Any of the elevation adjustment mechanisms and/or locking mechanismsdescribed above in connection with system 200 of FIGS. 5-11 may beincluded in pedestal 906 for controlling the telescopic raising andlowering of segment 922 relative to segment 924. A pair of releasehandles 938 are situated just below respective side regions of shelf 904and are moveable toward the shelf 904 from a locking position to areleasing position to unlock the elevation adjustment mechanism situatedin the interior region of telescopic column 920, thereby to permit theupper segment 922 of the column to be raised and lowered relative to thelower segment 924. In FIG. 52, only one of handles 938 can be seen.Handles 938 are normally biased toward the locking position having theassociated elevation adjustment mechanism looked.

In some embodiments, the elevation adjustment mechanism comprises alocking gas spring that, when unlocked, provides an upward force thatassists the user in overcoming the weight of segment 922 and all of theequipment carried thereon, during raising of segment 922 relative tosegment 924. In the illustrative embodiment, a pair of hand grips 940are coupled to the side regions of shelf 904 to provide any increasedthickness gripping area for a caregiver actuating handles 938 to changethe elevation of air pulse generator 902. Hand grips 940 also provide avisual indicia as to the relative location of handles 938 beneath shelf904 to a caregiver that otherwise may not be able to see handles 938directly. For example, a caregiver standing behind system 900 andpushing system 900 using handle 916 might not be able to see handles938. Hand grips 940 include portions that are above, below and alongsideshelf 904. Each hand grip 940 has a slot that receives a portion ofshelf 904 therein. In some embodiments, hand grips 940 are made of amaterial, such as rubber, having a greater resiliency than the materialfrom which shelf 904 is made to enhance the comfort of the caregivergrasping hand grips 940 and manipulating release handles 938.

Although certain illustrative embodiments have been described in detailabove, variations and modifications exist within the scope and spirit ofthis disclosure as described and as defined in the following claims.

1. A high frequency chest wall oscillation (HFCWO) therapy systemcomprising a garment to be worn adjacent a chest of a patient; an airpulse generator coupled to the garment and operable to deliver highfrequency pressure pulses to the garment; and a wheeled pedestal towhich the air pulse generator is coupled, the wheeled pedestal having ashelf that extends beyond a front of the air pulse generator and beyonda rear of the air pulse generator, the wheeled pedestal having aheight-adjustable column beneath the shelf, and the wheeled pedestalincluding a handle coupled to the shelf and grippable by a caregiver tomaneuver the wheeled pedestal and the air pulse generator along a floor.2. The HFCWO therapy system of claim 1, wherein the air pulse generatoris coupled to the shelf via one or more fasteners.
 3. The HFCWO therapysystem of claim 1, wherein the shelf also extends beyond sides of theair pulse generator.
 4. The HFCWO therapy system of claim 1, wherein thehandle comprises a tubular bar.
 5. The HFCWO therapy system of claim 1,wherein portions of the tubular bar extend laterally beyond sides of theshelf.
 6. The HFCWO therapy system of claim 1, wherein portions of thehandle are situated beneath the shelf.
 7. The HFCWO therapy system ofclaim 1, wherein the height-adjustable column of the wheeled pedestalcomprises a vertically oriented telescopic column having an uppersegment and a lower segment.
 8. The HFCWO therapy system of claim 7,wherein the upper segment is raised and lowered relative to the lowersegment to adjust the elevation at which the shelf supports the airpulse generator.
 9. The HFCWO therapy system of claim 7, wherein thewheeled pedestal comprises a plurality of legs coupled to the lowersegment of column and extending outwardly therefrom.
 10. The HFCWOtherapy system of claim 9, wherein the wheeled pedestal comprises aplurality of casters, each caster of the plurality of casters beingcoupled to a respective leg of the plurality of legs.
 11. The HFCWOtherapy system of claim 7, wherein the wheeled pedestal assemblyincludes a locking gas spring that is unlockable to permit thetelescopic column to extend and retract and that is lockable to maintainthe telescopic column at a desired length.
 12. The HFCWO therapy systemof claim 1, wherein the air pulse generator comprises at least onediaphragm that is moved cyclically back and forth to produce the highfrequency pressure pulses.
 13. The HFCWO therapy system of claim 12,wherein the at least one diaphragm comprises a pair of diaphragms. 14.The HFCWO therapy system of claim 1, wherein the air pulse generator isoperable to adjust the frequency of the high frequency pressure pulses.15. The HFCWO therapy system of claim 1, wherein the air pulse generatoris operable to provide high frequency pressure pulses in the range ofabout 5 Hertz to about 20 Hertz.
 16. The HFCWO therapy system of claim1, further comprising a spirometer integrated with the air pulsegenerator.
 17. The HFCWO therapy system of claim 1, further comprising anebulizer coupled to the air pulse generator.
 18. The HFCWO therapysystem of claim 17, wherein the air pulse generator comprises a housingthat carries a source of air for the nebulizer.
 19. The HFCWO therapysystem of claim 1, wherein the therapy system is also operable todeliver any one or more of the following therapies: a positiveexpiratory pressure (PEP) therapy, a nebulizer therapy, an intermittentpositive pressure breathing (IPPB) therapy, a cough assist therapy, asuction therapy, or a bronchial dilator therapy.
 20. The HFCWO therapysystem of claim 1, wherein the air pulse generator further comprises acontroller operable to control an amplitude of a steady state pressurecomponent, a frequency of the oscillating pressure component, and aduration of the HFCWO therapy. being displayed on the display to permita user to view portions of a user's manual on the display and to displaya video on the display regarding how to use the system.